Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02511834
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2015-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEST III PMS Clinical Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001026', 'term': 'Coronary Artery Bypass'}], 'ancestors': [{'id': 'D009204', 'term': 'Myocardial Revascularization'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2015-07-25', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.', 'timeFrame': '2 years', 'description': 'Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.'}], 'secondaryOutcomes': [{'measure': 'Intimal hyperplasia area', 'timeFrame': '2 years', 'description': 'Sub group (IVUS) - Intimal hyperplasia (plaque+media) area \\[mm2\\] as assessed by IVUS'}, {'measure': 'MACCE', 'timeFrame': '2 years', 'description': 'Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization'}, {'measure': 'Vein graft failure', 'timeFrame': '2 years', 'description': 'Defined as ≥50% stenosis by QCA'}, {'measure': 'Early vein graft failure', 'timeFrame': '6 months', 'description': 'Early vein graft failure, defined as \\>50% occlusion by CT Angio'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '29373645', 'type': 'DERIVED', 'citation': 'Amin S, Werner RS, Madsen PL, Krasopoulos G, Taggart DP. Influence of external stenting on venous graft flow parameters in coronary artery bypass grafting: a randomized study. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):926-931. doi: 10.1093/icvts/ivy007.'}]}, 'descriptionModule': {'briefSummary': 'Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient scheduled for on-pump CABG on clinical grounds\n2. Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds\n3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed\n4. Ability to give their informed written consent\n5. Ability and willingness to comply with study follow up requirements\n6. Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years\n\nExclusion Criteria:\n\n1. Concomitant non-CABG cardiac procedure\n2. Prior cardiac surgery\n3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)\n4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)\n5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest, before randomization\n6. Severe vein varicosity\n7. Prior debilitating stroke less than 1 year before surgery\n8. Severe renal dysfunction (Cr\\>2.0 mg/dL or \\>177 μmol/L)\n9. Women of child bearing age\n10. Concomitant life-threatening disease likely to limit life expectancy to less than 5 years\n11. Indication for Warfarin up to time of surgery\n12. Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.\n13. inability to take aspirin\n14. Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication\n15. Inability to comply with required follow-ups including angiographic and/or CT imaging methods.\n16. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study'}, 'identificationModule': {'nctId': 'NCT02511834', 'acronym': 'VEST III', 'briefTitle': 'VEST III PMS Clinical Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascular Graft Solutions Ltd.'}, 'orgStudyIdInfo': {'id': 'CD0113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VEST supported', 'description': 'Vein graft supported by VEST', 'interventionNames': ['Device: VEST External Support', 'Procedure: Coronary Artery Bypass Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Vein grafts unsupported by VEST', 'interventionNames': ['Procedure: Coronary Artery Bypass Surgery']}], 'interventions': [{'name': 'VEST External Support', 'type': 'DEVICE', 'armGroupLabels': ['VEST supported']}, {'name': 'Coronary Artery Bypass Surgery', 'type': 'PROCEDURE', 'otherNames': ['CABG'], 'armGroupLabels': ['Control', 'VEST supported']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'German Heart Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bernau', 'country': 'Germany', 'facility': 'Immanuel Hospital Bernau. Brandenburg Heart Center', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'West-German Heart Center Essen University', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Lübeck', 'country': 'Germany', 'facility': 'University Medical Center Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Trier', 'country': 'Germany', 'facility': 'Krankenhaus der Barmherzigen Bruder', 'geoPoint': {'lat': 49.75565, 'lon': 6.63935}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam - Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center Hospital', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Papworth Everard', 'state': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.24893, 'lon': -0.11827}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'University Hospitals Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'The John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascular Graft Solutions Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}