Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-02 @ 2:58 PM
Study NCT ID:
NCT03875651
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF) rate', 'timeFrame': '12-months', 'description': '12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Drug-Eluting Stents'], 'conditions': ['Atherosclerosis', 'Heart Diseases, Coronary', 'Coronary Artery Disease', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \\> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients include those with atherosclerotic coronary lesions with vessel diameters that can appropriately be treated with 4.50 mm and/or 5.00 mm stents according to the commercially approved SYNERGY DFU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm SYNERGY stent for the treatment of their disease in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki.\n\nExclusion Criteria:\n\n* Planned treatment with a non-SYNERGY stent.'}, 'identificationModule': {'nctId': 'NCT03875651', 'briefTitle': 'A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A U.S. Post-Approval Study of the SYNERGY 4.50/5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (Evolve 4.5/5.0)', 'orgStudyIdInfo': {'id': 'S2357'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SYNERGY 4.50 mm and 5.0 mm Coronary Stent System', 'type': 'DEVICE', 'description': 'The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Consultants', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconness Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64116', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'North Kansas City Hospital', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Medical Center', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lindner Center for Research and Education at Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Heart and Vascular Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22042', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Robert C Stoler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Heart and Vascular Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}