Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT03049657
Status:
COMPLETED
Last Update Posted:
2019-04-12
First Post:
2017-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2017-02-06', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy:Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority)', 'timeFrame': '6 months', 'description': 'Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority)'}, {'measure': 'Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))', 'timeFrame': '1 year', 'description': 'Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) during follow-up for no differences between Angiolite and Xience stents'}], 'secondaryOutcomes': [{'measure': 'Follow up', 'timeFrame': '1 year', 'description': 'Compare differences between Angiolite and Xience stent during the follow-up in independent components of the major adverse cardiac events rate: All cause death, any myocardial infarction and any revascularization'}, {'measure': 'Thrombosis rate', 'timeFrame': '1 year', 'description': 'Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience'}, {'measure': 'MACE (Major Adverse Cardiac Events)', 'timeFrame': '1 year', 'description': '\\- Compare the differences between the rate of MACE (all-cause death, any myocardial infarction and any revascularization) of Angiolite and Xience during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Drug-eluting Stent']}, 'descriptionModule': {'briefSummary': 'Clinical trial with an "European Community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent.\n\nClinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)\n\nA randomized clinical trial to compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.(non-inferiority design)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinical or subclinical ischemic heart disease with indication of percutaneous revascularization.\n* "De Novo" lesions ≥ 70%\n* Reference diameters ≥ 2 mm and ≤ 4 mm Accepted participation in the registration with the signing of informed consent\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Pregnancy\n* Intolerance or allergy to anti platelet or anticoagulant therapy\n* Elective surgical procedure scheduled within 6 months after inclusion in the study\n* Expectancy of life of less than 1 year.\n* Impossibility of doing 1 year clinical follow-up.\n* Primary angioplasty in patients with killip class III-IV or mechanical complications.\n* Patient with pre-procedure restenosis.\n* Patients who will not be treated all lesions with the Angiolite stent.\n* Total occlusions\n* Truncus disease'}, 'identificationModule': {'nctId': 'NCT03049657', 'briefTitle': 'Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardiva2 S.L.'}, 'officialTitle': 'Randomized Clinical Trial to Compare the Efficacy of Angiolite Stent Versus a Second-generation Drug-eluting Stent Such as Xience in Patients With Indication of Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'ANGIOLITE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ANGIOLITE', 'description': 'Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.', 'interventionNames': ['Device: Angiolite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xience', 'description': 'Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.', 'interventionNames': ['Device: Xience']}], 'interventions': [{'name': 'Angiolite', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention', 'armGroupLabels': ['ANGIOLITE']}, {'name': 'Xience', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention', 'armGroupLabels': ['Xience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '24001', 'city': 'León', 'state': 'León', 'country': 'Spain', 'facility': 'Hospital de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Virgen de la Arrixaca', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}, {'zip': '06006', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Valle de Hebrón', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '45005', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Virgen de la Salud', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Carlos Ibares', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiva2 S.L.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiva2 S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}