Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-20 @ 3:31 AM
Study NCT ID:
NCT04026204
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2019-06-12', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR', 'timeFrame': '5 minutes', 'description': 'Angiographic assessment of coronary ostia selective cannulation after TAVR'}], 'secondaryOutcomes': [{'measure': 'Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR', 'timeFrame': '5 minutes', 'description': 'Aortic root CTA measurements and prosthesis implantation-related factors associated with inability to selectively cannulate coronary ostia after TAVR at multivariate regression analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVR', 'Coronary cannulation', 'Transcatheter aortic prosthesis'], 'conditions': ['Aortic Stenosis', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '33069648', 'type': 'DERIVED', 'citation': 'Barbanti M, Costa G, Picci A, Criscione E, Reddavid C, Valvo R, Todaro D, Deste W, Condorelli A, Scalia M, Licciardello A, Politi G, De Luca G, Strazzieri O, Motta S, Garretto V, Veroux P, Giaquinta A, Giuffrida A, Sgroi C, Leon MB, Webb JG, Tamburino C. Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2542-2555. doi: 10.1016/j.jcin.2020.07.006. Epub 2020 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'With the upcoming expansion of transcatheter aortic valve replacement (TAVR) indications to younger patients, the feasibility of coronary ostia cannulation beyond different bioprosthesis stent is currently a matter of debate. Purpose of this study is: 1) to assess the feasibility to re-engage coronary ostia after TAVR; 2) to discover potential native anatomical or prosthesis-related features that may preclude proper coronary cannulation after TAVR.', 'detailedDescription': 'Single-center, prospective, pilot study. Aim of this study is to assess the feasibility of coronary ostia re-engagement beyond transcatheter aortic valve (TAV) stent through a transfemoral access in 300 consecutive patients undergoing transfemoral TAVR with pre-procedural computed tomography assessment available.\n\nThe possibility to selectively cannulate each coronary, the amount of time and contrast will be evaluated in each patient before and after implantation of either balloon-(SAPIEN 3) or self-expanding (Evolut R/PRO, Acurate Neo or Portico) TAVs, thus generating an internal comparator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic, severe aortic stenosis who underwent TAVR', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices\n* Availability of preprocedural aortic root evaluation by computed tomography angiography scans\n\nExclusion Criteria:\n\n* TAVR in degenerated bioprostheses\n* Known ostial chronic total occlusion\n* Transcatheter valve not deployed in its anatomical position\n* Patients with hemodynamic instability during the procedure'}, 'identificationModule': {'nctId': 'NCT04026204', 'acronym': 'RE-ACCESS', 'briefTitle': 'Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)', 'orgStudyIdInfo': {'id': 'UCatania001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary cannulation after TAVR', 'description': 'Coronary ostia cannulation after TAVR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'facility': 'Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Marco Barbanti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marco Barbanti', 'investigatorAffiliation': 'University of Catania'}}}}