Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT05333068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-04
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1222}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months', 'timeFrame': '24 months', 'description': 'cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months'}], 'secondaryOutcomes': [{'measure': 'Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm', 'timeFrame': '24 months', 'description': 'Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm'}, {'measure': 'Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months', 'timeFrame': '24 months', 'description': 'Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multivessel Coronary Artery Disease', 'Ischemia', 'Vulnerable Plaque', 'Coronary Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://diagramresearch.com/trials/', 'label': 'Diagram B.V.'}]}, 'descriptionModule': {'briefSummary': 'The COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation.', 'detailedDescription': 'The published COMBINE trial shows that patients carrying an OCT-detected thin-cap atheroma have a fivefold higher rate of the primary endpoint compared to patients without vulnerable lesion morphology, despite absence of ischemia. The most important finding of this trial is that not ischemia, but underlying lesion morphology could be the most important factor that predicts future adverse events. Together with the recently published ISCHEMIA trial, where ischemia guided revascularization failed to improve clinical outcomes compared to medical treatment, the COMBINE trial leads to a new way of thinking in interventional cardiology and also opens the door for new treatment strategies where a combined ischemic and morphologic assessment could lead to better clinical outcomes.\n\nThe COMBINE-INTERVENE Trial will investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation. The COMBINE-INTERVENE Trial is the first in line trial that will test focal percutaneous stenting for vulnerable plaque lesions independently from ischemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients undergoing PCI, aged 30-80 years with any clinical presentation\n2. Angiographic criteria: presence of ≥ 2 de novo target lesions\\* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)\n\nAngiographic criteria target lesion\\* (all criteria I-IV should be applicable):\n\nI. DS ≥ 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of ≥ 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)\n\n\\*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have ≥ 2 target lesions or one culprit and ≥ 1 target lesion.\n\nExclusion Criteria:\n\n1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)\n2. Lesion located in a grafted segment or in a vein graft\n3. In-stent restenosis lesions\n4. Left main trifurcation\n5. Left main lesion stand-alone (without other lesions)\n6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)\n7. Chronic total occlusion\n8. Spontaneous coronary dissection\n9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years\n10. Patients with left ventricle (LV) function less than 30%\n11. Renal insufficiency (Glomerular Filtration Rate (GFR) \\< 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)\n12. Life expectancy less than 3 years'}, 'identificationModule': {'nctId': 'NCT05333068', 'briefTitle': 'COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events', 'organization': {'class': 'OTHER', 'fullName': 'Diagram B.V.'}, 'officialTitle': 'COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events', 'orgStudyIdInfo': {'id': '9357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment', 'description': 'MVD \\> 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment', 'interventionNames': ['Procedure: PCI revascularization strategy based on combined FFR and OCT assessment']}, {'type': 'SHAM_COMPARATOR', 'label': 'MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)', 'description': 'MVD \\> 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)', 'interventionNames': ['Procedure: PCI revascularization strategy based FFR assessment']}], 'interventions': [{'name': 'PCI revascularization strategy based on combined FFR and OCT assessment', 'type': 'PROCEDURE', 'description': 'PCI revascularization strategy based on combined FFR and OCT assessment All FFR ≤ 0.75 and Vulnerable plaque will be treated. VP defined as TCFA ( cap thickness ≤ 75 micron); Ruptured plaque; or Plaque erosion with \\> 70 % AS or MLA \\< 2.5 mm2.', 'armGroupLabels': ['MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment']}, {'name': 'PCI revascularization strategy based FFR assessment', 'type': 'PROCEDURE', 'description': 'PCI revascularization strategy based FFR assessment (all lesions with FFR≤0.80 will be treated)', 'armGroupLabels': ['MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clayton', 'country': 'Australia', 'facility': 'Monash Medical', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Sciences'}, {'city': 'Ontario', 'country': 'Canada', 'facility': 'Niagara Health System - St. Catherines Site'}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North-Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional Universitaire de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Clinique Louis Pasteur', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Ahmedabad', 'country': 'India', 'facility': 'Apex Heart Institute', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Apollo Hospitals', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Chandigarh', 'country': 'India', 'facility': 'Post Graduate Institute of Medical education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Universitario Fondazione Agostino Gemelli', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Bunkyō City', 'country': 'Japan', 'facility': 'National University Corporation Institute of Science Tokyo', 'geoPoint': {'lat': 35.5331, 'lon': 139.4217}}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'National Heart Institute', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Hospital', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Elisabeth-TweeSteden Hospital', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Wellington Hospital', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}, {'city': 'Katowice', 'country': 'Poland', 'facility': 'Medical University of Silesia', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University; John Paul II Hospital', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'University Hospital Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lubin', 'country': 'Poland', 'facility': 'Miedziowe Centrum Zdrowia', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Regional Specialist Hospital', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'C.C. 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