Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-31 @ 8:13 AM
Study NCT ID:
NCT01262703
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2010-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of a Bioresorbable Coronary Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023903', 'term': 'Coronary Restenosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-27', 'studyFirstSubmitDate': '2010-12-16', 'studyFirstSubmitQcDate': '2010-12-16', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemia-driven Target Lesion Revascularization (TLR)', 'timeFrame': '6 months', 'description': 'Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.'}], 'secondaryOutcomes': [{'measure': 'QCA & IVUS derived parameters', 'timeFrame': '12 months', 'description': 'Late Loss, Restenosis Rate, %DS, MLD \\& Neointimal Volume'}, {'measure': 'Major Adverse Coronary Events', 'timeFrame': '60 months', 'description': 'Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK \\> 2xULN + MB\\>ULN) (MI), and target vessel revascularization (TVR).'}, {'measure': 'Procedural and Technical Success', 'timeFrame': 'Acute', 'description': 'percentage of patients with angiographic success successful delivery and deployment of the device'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myocardial Ischemia', 'Coronary Artery Stenosis', 'Coronary Disease', 'Coronary Artery Disease', 'Coronary Restenosis', 'Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.', 'detailedDescription': 'Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of myocardial ischemia or a positive functional study.\n* Normal CK-MB.\n* Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS\n* Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \\< 100% with a TIMI flow of ≥ 2.\n* Staged procedures are allowed in non-target vessels \\>24 hours before or \\> 30 days after REVA stent implantation\n\nExclusion Criteria:\n\n* A myocardial infarction (CK-MB or Troponin \\> 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus\n* Unprotected left main coronary disease with \\>50% stenosis\n* The target vessel is totally occluded (TIMI Flow 0 to 1)\n* Target lesion involves a bifurcation (a lesion with a side branch \\>2.0 mm in diameter containing a \\>50% stenosis)\n* Target lesion is located within a segment supplied by distal graft\n* Target lesion has possible or definite thrombus'}, 'identificationModule': {'nctId': 'NCT01262703', 'acronym': 'RESTORE', 'briefTitle': 'Safety Study of a Bioresorbable Coronary Stent', 'organization': {'class': 'INDUSTRY', 'fullName': 'REVA Medical, Inc.'}, 'officialTitle': 'Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent', 'orgStudyIdInfo': {'id': 'HCT1000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REVA Medical ReZolve Stent', 'description': 'ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent', 'interventionNames': ['Device: ReZolve Stent']}], 'interventions': [{'name': 'ReZolve Stent', 'type': 'DEVICE', 'description': 'ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent', 'armGroupLabels': ['REVA Medical ReZolve Stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Dante Pazzanese de Cardiologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Alexandre Abizaid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Dante Pazzanese de Cardiologia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'REVA Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}