Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-01-07 @ 7:07 AM
Study NCT ID:
NCT00286195
Status:
WITHDRAWN
Last Update Posted:
2015-05-13
First Post:
2006-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frontier Registry II Bifurcation Stent System Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was withdrawn due to a business decision.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2015-05-12', 'studyFirstSubmitDate': '2006-02-02', 'studyFirstSubmitQcDate': '2006-02-02', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Major Adverse Cardiac Events (MACE): Death, Q-wave and non-Q wave Myocardial Infarction, Target Lesion Revascularization (main branch and side branch) including PTCA and CABG at 6 months (180 days).', 'timeFrame': '180 days and one year'}, {'measure': 'Acute ischemic, hemorrhagic and vascular complications.', 'timeFrame': 'one year'}, {'measure': 'Target Vessel Failure (TVF) rate (Death, Q-wave and non-Q-wave Myocardial Infarction and Target Vessel Revascularization (TVR) including PTCA and CABG at one month (30 days) and six months (180 days) follow up.', 'timeFrame': '6 months'}, {'measure': 'Acute success of stent delivery, deployment, and post dilatation.', 'timeFrame': '30 days'}]}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'To assess the procedural success, performance, 30-day and 6 month clinical outcome of bifurcation stenting, and the six month incidence of clinically indicated target lesion revascularization with the use of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System in patients with de novo or restenotic bifurcation lesions.', 'detailedDescription': 'The purpose of this study is to assess the performance of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System (CBSS) with one and six months clinical outcomes, when used for bifurcation de novo or restenotic lesion treatment. The device allows for a stent to be implanted in the main branch and simultaneous preservation and access of the side branch for balloon dilatation or stenting when indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure.\n* Native parent vessel suitable to receive at least a 2.5mm x 18mm FRONTIER stent (\\>2.5mm and \\<4.0mm diameter with a side branch of \\>2.0mm) with a lesion length \\<15mm determined by visual assessment .\n* Target main branch vessel must be a major epicardial native vessel.\n* Appropriate lesion morphology.\n* Target lesion is restenosis following original treatment by PTCA only (no in-stent restenosis).\n\nExclusion Criteria:\n\n* Estimated artery reference diameter \\<2.5mm\n* Patients with diffuse disease defined as long segments of abnormal vessel without interposed areas of normal vessel\n* Target lesion contains thrombus.\n* Target lesion is aorto-ostial or left main stem location.\n* Untreated lesion \\>50% diameter stenosis proximal or distal to target lesion after the planned target lesion intervention.\n* Patients with a contraindication for anti-platelet / anti-coagulation therapy.\n* Target lesion distal to previously placed stents.\n* Fibrotic or calcified lesions that cannot be pre-dilated.'}, 'identificationModule': {'nctId': 'NCT00286195', 'briefTitle': 'Frontier Registry II Bifurcation Stent System Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'The Abbott Vascular MULTI -LINK FRONTIER Coronary Bifurcation Stent System Registry II', 'orgStudyIdInfo': {'id': 'Frontier Registry II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'I', 'description': 'Consecutive patients, open label', 'interventionNames': ['Device: Multi-Link Frontier Coronary Stent System']}], 'interventions': [{'name': 'Multi-Link Frontier Coronary Stent System', 'type': 'DEVICE', 'description': 'Bare metal stent', 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'D Dudek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Matt Kiely, Manager, Medical Information', 'oldOrganization': 'Abbott Vascular'}}}}