Brief Title
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
Official Title
Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
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.
Detailed Description
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. The 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.
Study Type
Observational [Patient Registry]
Primary Outcome
Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
Secondary Outcome
Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR
Condition
Aortic Stenosis
Study Arms / Comparison Groups
Coronary cannulation after TAVR
Description: Coronary ostia cannulation after TAVR
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
300
Start Date
December 1, 2018
Completion Date
February 1, 2020
Primary Completion Date
January 31, 2020
Eligibility Criteria
Inclusion Criteria: - Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices - Availability of preprocedural aortic root evaluation by computed tomography angiography scans Exclusion Criteria: - TAVR in degenerated bioprostheses - Known ostial chronic total occlusion - Transcatheter valve not deployed in its anatomical position - Patients with hemodynamic instability during the procedure
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Marco Barbanti, MD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04026204
Organization ID
UCatania001
Responsible Party
Principal Investigator
Study Sponsor
University of Catania
Study Sponsor
Marco Barbanti, MD, Principal Investigator, University of Catania
Verification Date
September 2020