Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-01 @ 5:37 PM
Study NCT ID:
NCT04274751
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2020-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-18', 'studyFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2020-02-16', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day death, stroke or embolic events, PVE or sepsis', 'timeFrame': '30 day', 'description': 'Combined endpoint of death, stroke or embolic events, PVE or sepsis at 30-day follow up.'}, {'measure': '1-year death, stroke or embolic events, PVE or sepsis', 'timeFrame': '1 year', 'description': 'Combined endpoint of death, stroke or embolic events, PVE or sepsis at 1-year follow up.'}, {'measure': 'Intraprocedural Vascular complications', 'timeFrame': 'Intraprocedural', 'description': 'Intraprocedural Vascular complications'}, {'measure': 'In-hospital Vascular complications', 'timeFrame': '7-days', 'description': 'In-hospital Vascular complications'}], 'secondaryOutcomes': [{'measure': 'Short term complications related to the approach.', 'timeFrame': '30-days', 'description': 'Short term complications related to the approach.'}, {'measure': 'Mid term complications related to the approach.', 'timeFrame': '1-year', 'description': 'Mid term complications related to the approach.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter aortic valve Implantation (TAVI)', 'Transaxillary approach'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '25443009', 'type': 'BACKGROUND', 'citation': "Brennan JM, Holmes DR, Sherwood MW, Edwards FH, Carroll JD, Grover FL, Tuzcu EM, Thourani V, Brindis RG, Shahian DM, Svensson LG, O'Brien SM, Shewan CM, Hewitt K, Gammie JS, Rumsfeld JS, Peterson ED, Mack MJ. The association of transcatheter aortic valve replacement availability and hospital aortic valve replacement volume and mortality in the United States. Ann Thorac Surg. 2014 Dec;98(6):2016-22; discussion 2022. doi: 10.1016/j.athoracsur.2014.07.051. Epub 2014 Oct 29."}, {'pmid': '12473543', 'type': 'BACKGROUND', 'citation': 'Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.'}, {'pmid': '19380001', 'type': 'BACKGROUND', 'citation': 'Kurra V, Schoenhagen P, Roselli EE, Kapadia SR, Tuzcu EM, Greenberg R, Akhtar M, Desai MY, Flamm SD, Halliburton SS, Svensson LG, Sola S. Prevalence of significant peripheral artery disease in patients evaluated for percutaneous aortic valve insertion: Preprocedural assessment with multidetector computed tomography. J Thorac Cardiovasc Surg. 2009 May;137(5):1258-64. doi: 10.1016/j.jtcvs.2008.12.013.'}, {'pmid': '22226233', 'type': 'BACKGROUND', 'citation': 'Caceres M, Braud R, Roselli EE. The axillary/subclavian artery access route for transcatheter aortic valve replacement: a systematic review of the literature. Ann Thorac Surg. 2012 Mar;93(3):1013-8. doi: 10.1016/j.athoracsur.2011.10.056. Epub 2012 Jan 5.'}, {'pmid': '17846311', 'type': 'BACKGROUND', 'citation': 'Walther T, Simon P, Dewey T, Wimmer-Greinecker G, Falk V, Kasimir MT, Doss M, Borger MA, Schuler G, Glogar D, Fehske W, Wolner E, Mohr FW, Mack M. Transapical minimally invasive aortic valve implantation: multicenter experience. Circulation. 2007 Sep 11;116(11 Suppl):I240-5. doi: 10.1161/CIRCULATIONAHA.106.677237.'}, {'pmid': '21805602', 'type': 'BACKGROUND', 'citation': 'Bapat V, Khawaja MZ, Attia R, Narayana A, Wilson K, Macgillivray K, Young C, Hancock J, Redwood S, Thomas M. Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):733-40. doi: 10.1002/ccd.23276. Epub 2011 Sep 26.'}, {'pmid': '22464036', 'type': 'BACKGROUND', 'citation': 'Modine T, Sudre A, Delhaye C, Fayad G, Lemesle G, Collet F, Koussa M. Transcutaneous aortic valve implantation using the left carotid access: feasibility and early clinical outcomes. Ann Thorac Surg. 2012 May;93(5):1489-94. doi: 10.1016/j.athoracsur.2012.01.030. Epub 2012 Mar 28.'}, {'pmid': '24814495', 'type': 'BACKGROUND', 'citation': "Greenbaum AB, O'Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, Lederman RJ. Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients: initial human experience. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2795-804. doi: 10.1016/j.jacc.2014.04.015. Epub 2014 May 7."}, {'pmid': '26543600', 'type': 'BACKGROUND', 'citation': 'Schofer N, Deuschl F, Conradi L, Lubos E, Schirmer J, Reichenspurner H, Blankenberg S, Treede H, Schafer U. Preferential short cut or alternative route: the transaxillary access for transcatheter aortic valve implantation. J Thorac Dis. 2015 Sep;7(9):1543-7. doi: 10.3978/j.issn.2072-1439.2015.07.27.'}, {'pmid': '22019110', 'type': 'BACKGROUND', 'citation': 'Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP, Thomas M, Kovac J, Spyt T, MacCarthy PA, Wendler O, Hildick-Smith D, Davies SW, Trivedi U, Blackman DJ, Levy RD, Brecker SJ, Baumbach A, Daniel T, Gray H, Mullen MJ. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol. 2011 Nov 8;58(20):2130-8. doi: 10.1016/j.jacc.2011.08.050. Epub 2011 Oct 20.'}, {'pmid': '29314570', 'type': 'BACKGROUND', 'citation': 'Amat-Santos IJ, Rojas P, Gutierrez H, Vera S, Castrodeza J, Tobar J, Goncalves-Ramirez LR, Carrasco M, Catala P, San Roman JA. Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral. Catheter Cardiovasc Interv. 2018 Nov 1;92(5):935-944. doi: 10.1002/ccd.27485. Epub 2018 Jan 3.'}, {'pmid': '24485611', 'type': 'BACKGROUND', 'citation': 'Garcia DC, Benjo A, Cardoso RN, Macedo FY, Chavez P, Aziz EF, Herzog E, Alam M, de Marchena E. Device stratified comparison among transfemoral, transapical and transubclavian access for Transcatheter Aortic Valve Replacement (TAVR): a meta-analysis. Int J Cardiol. 2014 Mar 15;172(2):e318-21. doi: 10.1016/j.ijcard.2013.12.162. Epub 2014 Jan 9. No abstract available.'}, {'pmid': '28118931', 'type': 'BACKGROUND', 'citation': 'Schafer U, Deuschl F, Schofer N, Frerker C, Schmidt T, Kuck KH, Kreidel F, Schirmer J, Mizote I, Reichenspurner H, Blankenberg S, Treede H, Conradi L. Safety and efficacy of the percutaneous transaxillary access for transcatheter aortic valve implantation using various transcatheter heart valves in 100 consecutive patients. Int J Cardiol. 2017 Apr 1;232:247-254. doi: 10.1016/j.ijcard.2017.01.010. Epub 2017 Jan 7.'}, {'pmid': '33315296', 'type': 'RESULT', 'citation': 'Amat-Santos IJ, Santos-Martinez S, Conradi L, Taramasso M, Poli A, Romaguera R, Pan M, Bagur R, Del Valle R, Nombela-Franco L, Bhadra OD, Aparisi A, Redondo A, Gutierrez H, Gomez I, Roman JAS. Transaxillary transcatheter ACURATE neo aortic valve implantation - The TRANSAX multicenter study. Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E291-E298. doi: 10.1002/ccd.29423. Epub 2020 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.', 'detailedDescription': 'Aortic stenosis (AS) is the most frequently treated heart valve disease in our society. Transcatheter aortic valve implantation (TAVI) was originally described through an antegrade transeptal route by Cribier and colleagues in 2002. Because of the complexity of the procedure and risks of damaging the mitral apparatus, this approach was abandoned in favor of less challenging alternatives, with transfemoral (TF) route as primary option. Nevertheless, the TF approach is not feasible or of high risk in between 15 and 35% of the patients and vascular complications have been shown to be an independent predictor of death warranting alternative access techniques for TAVI. In this regard, the transapical, direct aortic, transcarotid, transcaval, and transubclavian/transaxillary (TSc) implantation routes currently serve as alternative access options. The TSc approach was initially used in selected cases. However, recent series suggest that TSc may provide better outcomes than alternative routes when TF is inadequate. Additionally, same studies suggest that, as compared to TF approach, TSc TAVI may present lower rate of vascular complications with comparable rates of other major outcomes despite the worse baseline profile of patients who are considered inappropriate for TF procedures. Moreover, fully-percutaneous TSc approach can be successfully performed with low rate of complications as was recently proposed by some authors. However, comparisons have been based in small series of cases, most of them with former iteration of TAVI devices, and a formal prospective comparison has never been performed. Therefore, our aim is to gather all cases of fully-percutaneous TSc and TF approaches for TAVI in Spain and Portugal and compare the standardized safety and efficacy endpoints through a matched analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.\n\nAll-comers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent TAVI through transfemoral of transaxillary fully-percutaneous approach between January 2017 and January 2019.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04274751', 'acronym': 'TRANSAX', 'briefTitle': 'Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clínico Universitario de Valladolid'}, 'officialTitle': 'Comparison of Transaxillary and Transfemoral Fully-percutaneous Approaches for Transcatheter Aortic Valve Implantation: The TRANSAX Study', 'orgStudyIdInfo': {'id': 'CASVE PI-19-1428'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transaxillary', 'description': 'TAVI, transaxillary approach', 'interventionNames': ['Device: Transcatheter aortic valve implantation']}, {'label': 'Transfemoral', 'description': 'TAVI, transfemoral approach', 'interventionNames': ['Device: Transcatheter aortic valve implantation']}], 'interventions': [{'name': 'Transcatheter aortic valve implantation', 'type': 'DEVICE', 'description': 'Transcatheter aortic valve implantation', 'armGroupLabels': ['Transaxillary', 'Transfemoral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ignacio J. Amat Santos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Interventional Cardiology Unit', 'investigatorFullName': 'Ignacio J. Amat Santos', 'investigatorAffiliation': 'Hospital Clínico Universitario de Valladolid'}}}}