Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
RE-ACCESS
Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedSeptember 7, 2020
September 1, 2020
1.2 years
June 12, 2019
September 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
Angiographic assessment of coronary ostia selective cannulation after TAVR
5 minutes
Secondary Outcomes (1)
Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR
5 minutes
Study Arms (1)
Coronary cannulation after TAVR
Coronary ostia cannulation after TAVR
Eligibility Criteria
Patients with symptomatic, severe aortic stenosis who underwent TAVR
You may qualify if:
- Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices
- Availability of preprocedural aortic root evaluation by computed tomography angiography scans
You may not qualify if:
- TAVR in degenerated bioprostheses
- Known ostial chronic total occlusion
- Transcatheter valve not deployed in its anatomical position
- Patients with hemodynamic instability during the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele
Catania, 95123, Italy
Related Publications (1)
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.
PMID: 33069648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Barbanti, MD
University of Catania
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2019
First Posted
July 19, 2019
Study Start
December 1, 2018
Primary Completion
January 31, 2020
Study Completion
February 1, 2020
Last Updated
September 7, 2020
Record last verified: 2020-09