Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-01 @ 10:05 AM
Study NCT ID:
NCT02319733
Status:
TERMINATED
Last Update Posted:
2017-02-14
First Post:
2014-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'insufficient eligable subjects and new data on BVS', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-11', 'studyFirstSubmitDate': '2014-12-14', 'studyFirstSubmitQcDate': '2014-12-14', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in plaque cumulative score of signs of vulnerability on CT', 'timeFrame': '24 months'}, {'measure': 'nominal change in percent necrotic core and thin-cap fibroatheroma at VH-IVUS', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vulnerable Plaque']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess if implantation of a bioresorbable vascular scaffold (BVS) for intermediate coronary lesions with morphological signs of vulnerable plaque in patients prone for acute coronary syndromes (ACS) will stabilize the plaque, improve natural vasomotion and increase vascular diameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic patients between the age of 18 and 80 years\n* Morise Risk score of ≥9 (intermediate or high risk) but no proven ischemia (no positive troponin or ST-elevation)\n* Intermediate coronary lesion on CT scan (50-70% based on CT estimate) and a plaque with at least two of the following vulnerability criteria: Napkin ring sign, positive remodeling, low attenuation and spotty calcification\n* FFR negative lesion at coronary angiogram\n* Vessel diameter ≥2.5 mm on visual estimate\n* GFR ≥ 45mL/min/1.73m².\n\nExclusion Criteria:\n\n* High calcium score on CT scan preventing adequate evaluation of the coronary lesion.\n* Lesions located in a coronary vessels previously stented.\n* Lesions located at a bifurcation\n* lesions involving an epicardial side branch ≥2 mm in diameter by visual assessment\n* the presence of thrombus or another clinically significant stenosis in the target vessel.\n* Left main (\\>50%) or known three vessel disease.\n* Patients presenting with acute myocardial infarction, unstable arrhythmias, or patients who have a left ventricular ejection fraction \\<30%\n* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparine or Everolimus and known true anaphylaxis to prior contrast media or known bleeding diathesis or known coagulopathy.\n* Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after inclusion.\n* History of stent thrombosis\n* Malignancies or other comorbidity with a life expectancy of less than one year or that may result in protocol noncompliance\n* Pregnancy (present, suspected or planned) or positive pregnancy test (in women with childbearing potential a negative pregnancy test is mandatory)'}, 'identificationModule': {'nctId': 'NCT02319733', 'briefTitle': 'Plaque Stabilization and Restoration by Bioresorbable Vascular Scaffold', 'organization': {'class': 'OTHER', 'fullName': 'Canisius-Wilhelmina Hospital'}, 'officialTitle': 'Plaque Stabilization and Restoration of Vascular Function by Bioresorbable Vascular Scaffold in Acute Coronary Syndrome Prone Patients', 'orgStudyIdInfo': {'id': '2013/498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioresorbable vascular scaffold', 'description': 'Implantation of Bioresorbable vascular scaffold in vulnerable plaques', 'interventionNames': ['Device: Bioresorbable vascular scaffold']}], 'interventions': [{'name': 'Bioresorbable vascular scaffold', 'type': 'DEVICE', 'description': 'Implantation of Bioresorbable vascular scaffold in vulnerable plaques', 'armGroupLabels': ['Bioresorbable vascular scaffold']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6532 SZ', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Canisuis Wilhelmina Hospital', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canisius-Wilhelmina Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr.', 'investigatorFullName': 'M.E.R. Gomes', 'investigatorAffiliation': 'Canisius-Wilhelmina Hospital'}}}}