Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02486068
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2015-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1670}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2015-06-24', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)', 'timeFrame': '1 year', 'description': 'Composite of:\n\n* Cardiac death\n* Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI)\n* Clinically Indicated Target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'superiority of the Absorb to the Xience in TLF between 3 and 7 years', 'timeFrame': '5 years'}, {'measure': 'Superiority of the Absorb to the Xience in TLF at 7 years', 'timeFrame': '7 years'}, {'measure': 'Superiority of the Absorb to the XIence in cumulative angina rate at 1 year', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Lesion']}, 'referencesModule': {'references': [{'pmid': '31153846', 'type': 'DERIVED', 'citation': 'Chang CC, Onuma Y, Achenbach S, Barbato E, Chevalier B, Cook S, Dudek D, Escaned J, Gori T, Kocka V, Tarantini G, West NEJ, Morice MC, Tijssen JGP, van Geuns RJ, Smits PC; COMPARE ABSORB trial investigators. Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial. Cardiovasc Revasc Med. 2019 Jul;20(7):577-582. doi: 10.1016/j.carrev.2019.04.013. Epub 2019 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this trial are:\n\nIn patients at high-risk for restenosis,\n\n* To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year\n* To assess superiority of the BRS to the EES in TLF between 3 and 7 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients (18-75 years old) with at least one of the followings:\n\n* High-risk characteristics for restenosis\n\n * Medically treated Diabetes (oral medication or insulin)\n * Multivessel disease of which more than one de-novo target lesion to be treated with the study scaffold/stent\n* Complex target lesion\n\n * Single de-novo target lesion satisfying at least one of the following:\n * Lesion length \\>28 mm\n * Small vessels: Target lesion reference vessel diameter between ≥2.5 mm and ≤2.75mm\n * Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)\n * Bifurcation with single stent strategy\n\nExclusion Criteria:\n\n* Patients are excluded from this study if they have:\n* Age \\<18 years or \\>75 years\n* Known comorbidities which make patients unable to complete 7-years follow-up\n* Female of childbearing potential (and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy\n* Pregnant woman\n* Breastfeeding woman\n* Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material\n* Cardiogenic Shock (Killip \\>2)\n* PCI with implantation of stents/scaffolds within previous 30 days.\n* Active bleeding or coagulopathy or patients at chronic anticoagulation therapy\n* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint\n* Renal insufficiency (GFR \\<45 ml/min)\n* Life expectancy \\< 7 years\n* Known non-adherence to DAPT\n* Patients on oral anticoagulation therapy (including novel oral anticoagulant such as dabigatran, rivaroxaban, apixaban and edoxaban)\n* LVEF \\<30%\n* Patients at high bleeding risk who are not suitable for long-term DAPT\n* Following lesion characteristics:\n\n * Target lesion reference vessel diameter (RVD) \\< 2.5 and \\> 4 mm\n * STEMI with RVD of \\>3.5mm of the culprit target lesion\n * Target lesion with in-stent/scaffold thrombosis\n * Graft lesions as target lesions\n * Aorto-ostial lesion(s)\n * Left main lesion\n * Severe tortuosity of target vessel\n * In-scaffold restenosis\n * Bifurcation target lesion with intended 2 stent/scaffold strategy\n* Non-target lesion and target lesion in the same epicardial coronary artery (right coronary artery, left circumflex artery or left anterior descending artery)'}, 'identificationModule': {'nctId': 'NCT02486068', 'acronym': 'Compare Absorb', 'briefTitle': 'ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis', 'organization': {'class': 'NETWORK', 'fullName': 'European Cardiovascular Research Center'}, 'officialTitle': 'ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis', 'orgStudyIdInfo': {'id': 'COMPARE ABSORB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABSORB scaffold', 'description': 'Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with ABSORB scaffold.', 'interventionNames': ['Device: ABSORB scaffold']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xience', 'description': 'Patient will undergoes elective or emergent percutaneous coronary intervention and will be treated with Xience Prime.', 'interventionNames': ['Device: Xience']}], 'interventions': [{'name': 'ABSORB scaffold', 'type': 'DEVICE', 'armGroupLabels': ['ABSORB scaffold']}, {'name': 'Xience', 'type': 'DEVICE', 'armGroupLabels': ['Xience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Cardiovascular Center Aalst OLV', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'CHR Citadelle', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '10034', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Cardiocentre, University Hospital Kralovske', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '1200', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Central Military Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '84082', 'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhône Durance', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '91300', 'city': 'Massy', 'country': 'France', 'facility': 'Hôpital Privé Jacques Cartier', 'geoPoint': {'lat': 48.72692, 'lon': 2.28301}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Saint-Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '23795', 'city': 'Bad Segeberg', 'country': 'Germany', 'facility': 'Segeberger Kliniken', 'geoPoint': {'lat': 53.93775, 'lon': 10.30745}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45138', 'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabethkrankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '33539', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universität Leipzig - Herzzentrum', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '09134', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Brotzu', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '31033', 'city': 'Castelfranco Veneto', 'country': 'Italy', 'facility': 'Ospedale San Giacomo', 'geoPoint': {'lat': 45.67146, 'lon': 11.92755}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Università degli studi Magna Graecia', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Università degli Studi di Napoli Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Arnas Civico Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '4818', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '3300', 'city': 'Dordrecht', 'country': 'Netherlands', 'facility': 'Albert Schweitzer Hospital', 'geoPoint': {'lat': 51.81, 'lon': 4.67361}}, {'zip': '5623', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catherina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '3000', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3079', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Maasstadziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '40-635', 'city': 'Chrzanów', 'country': 'Poland', 'facility': 'American Heart of Poland', 'geoPoint': {'lat': 50.13546, 'lon': 19.40203}}, {'zip': '31-501', 'city': 'Krakow', 'country': 'Poland', 'facility': 'University Hospital Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '59-301', 'city': 'Lubin', 'country': 'Poland', 'facility': 'Miedziowe Centrum Zdrowia SA', 'geoPoint': {'lat': 51.40089, 'lon': 16.20149}}, {'zip': '43-100', 'city': 'Tychy', 'country': 'Poland', 'facility': 'American Heart of Poland', 'geoPoint': {'lat': 50.13717, 'lon': 18.96641}}, {'zip': '8003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 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Center', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}