Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-17 @ 12:36 PM
Study NCT ID:
NCT02453035
Status:
TERMINATED
Last Update Posted:
2021-04-26
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DESolve® X-Pand Global Post Market Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'slow enrollment due to change in worldwide scaffold usage', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2015-05-13', 'studyFirstSubmitQcDate': '2015-05-20', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TLF (Target Lesion Failure)', 'timeFrame': '12 months', 'description': 'TLF is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)'}, {'measure': 'Death', 'timeFrame': '12 months', 'description': 'All cause mortality'}, {'measure': 'MI', 'timeFrame': '12 months', 'description': 'Myocardial Infarction'}, {'measure': 'CABG', 'timeFrame': '12 months', 'description': 'Emergency bypass surgery (CABG)'}, {'measure': 'CD-TVR', 'timeFrame': '12 months', 'description': 'Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)'}], 'secondaryOutcomes': [{'measure': 'Thrombosis', 'timeFrame': '12 months', 'description': 'Thrombosis: The ARC stent thrombosis criteria are applied'}, {'measure': 'Device Success', 'timeFrame': 'day of treatment procedure', 'description': 'Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \\< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met'}, {'measure': 'Procedure Success', 'timeFrame': '30 days', 'description': 'Successful delivery and deployment of the DESolve scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \\< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.'}, {'measure': 'MACE', 'timeFrame': '3 years', 'description': 'MACE is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioresorbable scaffold', 'CAD'], 'conditions': ['Coronary Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The X-Pand Registry is intended to facilitate analysis of acute \\& long-term safety as well as treatment outcomes with DESolve in patients with CAD.', 'detailedDescription': 'The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold.\n\nThe Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines \\& internal hospital guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who have received implants of one or more DESolve scaffold(s)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Minimal age 18 years\n2. Patient is willing/able to cooperate with study procedures and required follow up visits. Patient or legal representative has been informed \\& agrees by signing EC approved written consent. Consent can occur before implantation of the DESolve scaffold (planned procedure) or within 30 days post implantation procedure for retrospective enrollment (unplanned procedure).\n3. Planned or unplanned DESolve scaffold implantation\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02453035', 'acronym': 'X-Pand', 'briefTitle': 'DESolve® X-Pand Global Post Market Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elixir Medical Corporation'}, 'officialTitle': 'X-Pand is Intended to Use the DESolve Scaffold System in Treatment of CAD Patients, by Including "Real World" Use of the DESolve Scaffold Over a Broad Spectrum of Geographies, A Wide Variety of Practicing Clinicians & A Minimum Degree Of Selection Criteria', 'orgStudyIdInfo': {'id': 'ELX-CL-1503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PTCA - Desolve Scaffold', 'description': 'Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold', 'interventionNames': ['Device: PTCA - Desolve Scaffold']}], 'interventions': [{'name': 'PTCA - Desolve Scaffold', 'type': 'DEVICE', 'otherNames': ['PTA. PCI'], 'description': 'Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold', 'armGroupLabels': ['PTCA - Desolve Scaffold']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff-Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '65428', 'city': 'Rüsselsheim am Main', 'country': 'Germany', 'facility': 'GPR Klinikum Rüsselsheim', 'geoPoint': {'lat': 49.98955, 'lon': 8.42251}}, {'zip': '54292', 'city': 'Trier', 'country': 'Germany', 'facility': 'Krankenhaus der Barmherzigen Brüder', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'zip': '3430', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Jean Fajadet, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Toulouse'}, {'name': 'Holger Nef, Prof Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Giessen und Marburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elixir Medical Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'European Cardiovascular Research Center', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}