Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT03084367
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2017-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Physiologic Assessment of Coronary Stenosis Following PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D060050', 'term': 'Angina, Stable'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'becky.inderbitzen@philips.com', 'phone': '+1.858.764.1336', 'title': 'Becky Inderbitzen, Global Director, Clinical Development', 'organization': 'Philips (Volcano)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported.', 'description': 'As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects.\n\nSubjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'description': 'all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.', 'otherNumAtRisk': 467, 'deathsNumAtRisk': 467, 'otherNumAffected': 0, 'seriousNumAtRisk': 467, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Target Vessel Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 467, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia-driven Target Vessel Revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 467, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 467, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 467, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Residual Ischemia (iFR <0.90)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}]}, {'units': 'Number of vessels in 467 participants', 'counts': [{'value': '535', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'description': 'all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'end of procedure/intervention', 'description': 'Residual ischemia is defined as iFR measurement \\<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \\<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\\<0.90) after a PCI that appeared to be successful based on angiography.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of vessels in 467 participants', 'denomUnitsSelected': 'Number of vessels in 467 participants', 'populationDescription': 'Total vessels/units (535) in participant population (467)'}, {'type': 'SECONDARY', 'title': 'Cardiac Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR >= 0.90', 'description': 'Participants with iFR \\>= 0.90 post-procedure'}, {'id': 'OG001', 'title': 'iFR < 0.90', 'description': 'Participants with iFR \\< 0.90 post-procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number of participants was divided in two groups based on their post-PCI iFR result. (see primary endpoint) The total number of participants still in study at one year is 467.'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR >= 0.90', 'description': 'Participants with iFR \\>= 0.90 post-procedure'}, {'id': 'OG001', 'title': 'iFR < 0.90', 'description': 'Participants with iFR \\< 0.90 post-procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number of participants was divided in two groups based on their post-PCI iFR result. (see primary endpoint) The total number of participants still in study at one year is 467.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Change From Baseline to 12 Months Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR <= 0.94', 'description': 'post-procedural iFR \\<= 0.94'}, {'id': 'OG001', 'title': 'iFR > 0.94', 'description': 'post-procedural iFR \\> 0.94'}], 'classes': [{'categories': [{'measurements': [{'value': '21.42', 'spread': '24.99', 'groupId': 'OG000'}, {'value': '20.73', 'spread': '21.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months).\n\nMinimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score.\n\nOutcome is the change in score from baseline to 12 months follow-up.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR >= 0.90', 'description': 'Participants with iFR \\>= 0.90 post-procedure'}, {'id': 'OG001', 'title': 'iFR < 0.90', 'description': 'Participants with iFR \\< 0.90 post-procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'All-cause and cardiac mortality at one year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Vessel MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR >= 0.90', 'description': 'Participants with iFR \\>= 0.90 post-procedure'}, {'id': 'OG001', 'title': 'iFR < 0.90', 'description': 'Participants with iFR \\< 0.90 post-procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Target vessel Myocardial infarction at one year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Vessel Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR >= 0.90', 'description': 'Participants with iFR \\>= 0.90 post-procedure'}, {'id': 'OG001', 'title': 'iFR < 0.90', 'description': 'Participants with iFR \\< 0.90 post-procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Ischemia-driven target vessel revascularization at one year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recurrent Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '355', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'iFR >= 0.90', 'description': 'Participants with iFR \\>= 0.90 post-procedure'}, {'id': 'OG001', 'title': 'iFR < 0.90', 'description': 'Participants with iFR \\< 0.90 post-procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'Recurrent ischemia at one-year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Correlation Between iFR and Angiographic Visual Interpretation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'description': 'all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure/intervention', 'description': 'Correlation between iFR \\<0.90 and coronary stenosis \\>50% assessed by visual interpretation.\n\nThis was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject.\n\nAn absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography.\n\nOutcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR \\<0.90 and coronary stenosis \\>50% assessed by visual interpretation the correlation is 1).', 'unitOfMeasure': 'coefficient of determination (R2)', 'reportingStatus': 'POSTED', 'populationDescription': 'The correlation calculation was performed on the total number of analyzable participants with a post-PCI iFR pullback assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'description': 'all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Procedural', 'description': 'Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis assumes that all focal lesions with post-PCI iFR \\<0.90 were successfully treated with additional PCI. Using the cutoff of iFR \\<0.90, the outcome is the number of participants that would remain, or not have been treated, because the iFR measurements are under 0.90.'}, {'type': 'SECONDARY', 'title': 'Differentiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}, {'units': 'vessels', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Residual Ischemia (Post-PCI iFR <0.90) After Angiographically Successful PCI', 'description': 'Residual ischemia (post-PCI iFR \\<0.90)'}], 'classes': [{'title': 'single or multiple residual focal lesions', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'diffuse disease', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of procedure /intervention', 'description': 'Differentiation of the cause for impaired iFR', 'unitOfMeasure': 'vessels', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'vessels', 'denomUnitsSelected': 'vessels', 'populationDescription': 'Number of vessels in which residual ischemia (post-PCI iFR \\<0.90) after angiographically successful PCI'}, {'type': 'SECONDARY', 'title': 'Delta iFR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '467', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'description': 'all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.'}], 'classes': [{'title': 'pre-PCI reference vessel diameter', 'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'lesion location in left anterior descending coronary artery', 'categories': [{'measurements': [{'value': '5.65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the end of the procedure/intervention', 'description': 'Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be \\<0.90. An OR \\> 1 means greater odds that the post-PCI iFR is \\<0.90, OR = 1 means there is no association, and OR \\< 1 means there is a lower odds that the post-PCI iFR is \\<0.90.', 'unitOfMeasure': 'Odds ratio', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'description': 'all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}]}, {'type': 'Analyzable iFR Pullback Assessment Post Angiographically Successful PCI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '467'}]}, {'type': 'COMPLETED', 'comment': 'completed means study follow-up at 1 year completed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '463'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic Test: iFR Pullback', 'description': 'iFR (instantaneous wave free ratio) pullback assessment post angiographically successful PCI'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '379', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.8', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoker', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Mellitus', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insulin treated diabetes', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hyperlipidemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '351', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '383', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Renal disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Percutaneous Coronary Intervention (PCI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Myocardial Infarction', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '134', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Left ventricular ejection fraction (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.3', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of blood ejected with each contraction', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stable angina', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Unstable Angina', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '155', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'NSTEMI (Non-ST Elevated Myocardial Infarction)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Silent Ischemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recent STEMI (ST Elevated MI) (>7days)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '500', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-26', 'size': 775989, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-06-29T10:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-21', 'studyFirstSubmitDate': '2017-03-13', 'resultsFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-21', 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Residual Ischemia (iFR <0.90)', 'timeFrame': 'end of procedure/intervention', 'description': 'Residual ischemia is defined as iFR measurement \\<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \\<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\\<0.90) after a PCI that appeared to be successful based on angiography.'}], 'secondaryOutcomes': [{'measure': 'Cardiac Events', 'timeFrame': '12 months', 'description': 'Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI'}, {'measure': 'Target Vessel Failure', 'timeFrame': '12 months', 'description': 'Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization'}, {'measure': 'Quality of Life Change From Baseline to 12 Months Follow-up', 'timeFrame': '12 months', 'description': 'Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months).\n\nMinimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score.\n\nOutcome is the change in score from baseline to 12 months follow-up.'}, {'measure': 'Cardiac Mortality', 'timeFrame': '12 months', 'description': 'All-cause and cardiac mortality at one year'}, {'measure': 'Target Vessel MI', 'timeFrame': '12 month', 'description': 'Target vessel Myocardial infarction at one year'}, {'measure': 'Target Vessel Revascularization', 'timeFrame': '12 month', 'description': 'Ischemia-driven target vessel revascularization at one year'}, {'measure': 'Recurrent Ischemia', 'timeFrame': '12 month', 'description': 'Recurrent ischemia at one-year'}, {'measure': 'Correlation Between iFR and Angiographic Visual Interpretation', 'timeFrame': 'at the end of the procedure/intervention', 'description': 'Correlation between iFR \\<0.90 and coronary stenosis \\>50% assessed by visual interpretation.\n\nThis was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject.\n\nAn absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography.\n\nOutcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR \\<0.90 and coronary stenosis \\>50% assessed by visual interpretation the correlation is 1).'}, {'measure': 'Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI', 'timeFrame': 'Procedural', 'description': 'Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI'}, {'measure': 'Differentiation', 'timeFrame': 'End of procedure /intervention', 'description': 'Differentiation of the cause for impaired iFR'}, {'measure': 'Delta iFR', 'timeFrame': 'at the end of the procedure/intervention', 'description': 'Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be \\<0.90. An OR \\> 1 means greater odds that the post-PCI iFR is \\<0.90, OR = 1 means there is no association, and OR \\< 1 means there is a lower odds that the post-PCI iFR is \\<0.90.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Coronary Stenosis', 'Angina, Unstable', 'Angina, Stable']}, 'referencesModule': {'references': [{'pmid': '31648761', 'type': 'RESULT', 'citation': 'Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054.'}, {'pmid': '34991824', 'type': 'DERIVED', 'citation': 'Patel MR, Jeremias A, Maehara A, Matsumura M, Zhang Z, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp ASP, Ali ZA, Mintz G, Davies J, Stone GW. 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC Cardiovasc Interv. 2022 Jan 10;15(1):52-61. doi: 10.1016/j.jcin.2021.09.042.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).', 'detailedDescription': 'DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR\\<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consented subjects with CAD who undergo physiologic lesion assessment with iFR\\<0.90 in at least 1 coronary artery are eligible for participation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must be \\> 18 years old\n2. Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)\n3. Single vessel CAD with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm OR multi-vessel CAD, defined as at least 2 vessels with ≥40% stenosis\n4. Pre-PCI iFR performed in all vessels intended for PCI\n5. Pre-PCI iFR of \\<0.90 of at least 1 stenosis\n6. Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant for the duration of the study\n2. Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days\n3. Cardiogenic shock (sustained (\\>10 min) systolic blood pressure \\< 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).\n4. Ionotropic or temporary pacing requirement\n5. Sustained ventricular arrhythmias\n6. Prior CABG (Coronary Artery Bypass Graft)\n7. Known ejection fraction ≤30%\n8. Chronic Total Occlusion (CTO)\n9. Known severe mitral or aortic stenosis.\n10. Any known medical comorbidity resulting in life expectancy \\< 12 months.\n11. Participation in any investigational study that has not yet reached its primary endpoint.\n12. Known severe renal insufficiency (eGFR \\<30 ml/min/1.72 m2).\n13. TIMI flow \\<3 at baseline\n14. Intra-coronary thrombus on baseline angiography'}, 'identificationModule': {'nctId': 'NCT03084367', 'acronym': 'DEFINE PCI', 'briefTitle': 'Physiologic Assessment of Coronary Stenosis Following PCI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Volcano Corporation'}, 'officialTitle': 'DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI', 'orgStudyIdInfo': {'id': '160101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'iFR post angiographically successful PCI', 'interventionNames': ['Diagnostic Test: iFR pullback']}], 'interventions': [{'name': 'iFR pullback', 'type': 'DIAGNOSTIC_TEST', 'description': 'iFR pullback assessment post angiographically successful PCI', 'armGroupLabels': ['iFR post angiographically successful PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80204', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Heart and Vascular', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rockford CV Associates', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '11706', 'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'facility': 'South Side Hospital', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northshore Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/NewYork Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital -Weill Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'St Francis Hospital', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY- Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27835', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Vidant Medical Center', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Miriam Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wellmont CVA Heart Insitute', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora St Lukes Medical Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'AMC Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'SS165NL', 'city': 'Basildon', 'country': 'United Kingdom', 'facility': 'Basildon Univeristy Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'EX25DW', 'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Royal Devon & Exeter NHS Foundation Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'W12OHS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College of London- Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Becky Inderbitzen, MSE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Philips (Volcano)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Volcano Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}, {'name': 'Cardiovascular Research Foundation, New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}