Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-03 @ 12:18 AM
Study NCT ID:
NCT00676494
Status:
COMPLETED
Last Update Posted:
2009-07-09
First Post:
2008-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'petersk@pathwaymedical.com', 'phone': '425-636-4053', 'title': 'Kevin Peters/Director of Clinical Affairs', 'organization': 'Pathway Medical Technologies, Inc.'}, 'certainAgreement': {'otherDetails': 'Investigators will have the right to publish results of the Study, provided that Investigators submit copies of any proposed publication to Sponsor for review at least 30 days and up to 60 days in advance of publication. Sponsor may extend such review period for another 90 days to file patent applications or protect its Related Rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Average Rutherford Classification Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients meeting eligibility criteria and enrolled in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.'}, {'type': 'SECONDARY', 'title': 'Average Ankle Brachial Index (ABI) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients meeting eligibility criteria and enrolled in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)', 'unitOfMeasure': 'units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.'}, {'type': 'SECONDARY', 'title': 'Freedom From Target Lesion Revascularization (TLR) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients meeting eligibility criteria and enrolled in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of patients that did not require target lesion revascularization 6 months after index procedure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.'}, {'type': 'PRIMARY', 'title': 'Major Adverse Events (MAEs) Within 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Patients meeting eligibility criteria and enrolled in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of study participants was statistically determined by protocol-defined endpoints. Analysis endpoints were assessed via summary statistics and 95% confidence intervals. No p-values were generated and no statistical inferences asserted regarding point estimates or confidence limits generated for any additional post-hoc data analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'Patients meeting eligibility criteria and enrolled in the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'Patients meeting eligibility criteria and enrolled in the study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '8.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-18', 'studyFirstSubmitDate': '2008-05-08', 'resultsFirstSubmitDate': '2009-02-23', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-05-18', 'studyFirstPostDateStruct': {'date': '2008-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Events (MAEs) Within 30 Days', 'timeFrame': '30 days', 'description': 'Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.'}], 'secondaryOutcomes': [{'measure': 'Average Rutherford Classification Score at 6 Months', 'timeFrame': '6 months', 'description': 'Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)'}, {'measure': 'Average Ankle Brachial Index (ABI) at 6 Months', 'timeFrame': '6 months', 'description': 'Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)'}, {'measure': 'Freedom From Target Lesion Revascularization (TLR) at 6 Months', 'timeFrame': '6 months', 'description': 'Number of patients that did not require target lesion revascularization 6 months after index procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '19995118', 'type': 'DERIVED', 'citation': 'Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62. doi: 10.1583/09-2826.1.'}]}, 'descriptionModule': {'briefSummary': 'The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature.\n\nThis is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented symptomatic atherosclerotic peripheral vascular disease\n* Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries\n* The patient has been informed of the nature of the study and has provided informed consent\n* The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits\n\nExclusion Criteria:\n\n* Target lesion is located in the iliac artery.\n* Target lesion stenosis is \\< 70%.\n* Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.\n* Patient is unable to participate for the duration of the study.\n* Patient is currently participating or has participated in a study with another investigational medical device or medication.'}, 'identificationModule': {'nctId': 'NCT00676494', 'briefTitle': 'The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pathway Medical Technologies Inc.'}, 'officialTitle': 'A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions', 'orgStudyIdInfo': {'id': 'PTC 05003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pathway PV Atherectomy System', 'type': 'DEVICE', 'description': 'The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas Zeller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herz Zentrum Bad Krozingen, Germany'}, {'name': 'Dierk Scheinert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pathway Medical Technologies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kevin Peters, Director of Clinical Affairs', 'oldOrganization': 'Pathway Medical Technologies Inc.'}}}}