Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05750927
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2023-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}, {'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POCE', 'timeFrame': '1 year', 'description': 'all-cause deaths, strokes (any), myocardial infarction and major bleedings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis', 'Transcatheter Aortic Valve Replacement', 'Angioplasty, Balloon, Coronary', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '40259842', 'type': 'DERIVED', 'citation': 'Montalto C, Munafo AR, Soriano F, Arslani K, Brunner S, Verhemel S, Cozzi O, Mangieri A, Buono A, Squillace M, Nava S, Diez Gil JL, Scotti A, Foroni M, Esposito G, Mandurino-Mirizzi A, Bauer D, Ornelas B, Codner P, Piayda K, Porto I, Marco F, Sievert H, Kornowski R, Tousek P, Fischetti D, Latib A, Sanchez JS, Maffeo D, Bedogni F, Reimers B, Regazzoli D, Mieghem NV, Sondergaard L, Saia F, Toggweiler S, Backer O, Oreglia JA. Outcomes of complex, high-risk percutaneous coronary intervention in patients with severe aortic stenosis: the ASCoP registry. EuroIntervention. 2025 Apr 21;21(8):e426-e436. doi: 10.4244/EIJ-D-24-00933.'}]}, 'descriptionModule': {'briefSummary': 'To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI', 'detailedDescription': 'The aims of this study are:\n\n* to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI\n* to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes\n* to investigate predictors of better outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe, symptomatic aortic stenosis with an indication to TAVI 2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)', 'eligibilityCriteria': '1. Severe, symptomatic aortic stenosis with an indication to TAVI\n2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)\n\n 1. Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI\n 2. Three-vessel disease\n 3. Last remaining vessel\n 4. Bifurcation PCI (proximal bifurcation)\n 5. Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon)\n 6. Lesion length \\> 30 mm\n 7. Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO'}, 'identificationModule': {'nctId': 'NCT05750927', 'acronym': 'ASCOP', 'briefTitle': 'Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Niguarda Hospital'}, 'officialTitle': 'Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes', 'orgStudyIdInfo': {'id': '723-1412202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASCoP (severe Aortic Stenosis with Complex PCI features)', 'description': 'Subjects with severe aortic stenosis undergoing transcatheter aortic valve intervention and with concomitant, complex coronary artery disease with a clinical indication for percutaneous coronary intervention', 'interventionNames': ['Procedure: Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)']}], 'interventions': [{'name': 'Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)', 'type': 'PROCEDURE', 'description': "TAVI and PCI to be administered as per physician's indication and choice, in one or more stages", 'armGroupLabels': ['ASCoP (severe Aortic Stenosis with Complex PCI features)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST GOM Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niguarda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}