Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)

University of Catania

Status: Completed

Conditions: Coronary Artery Disease; Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT04026204

UCatania001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Coronary cannulation after TAVR

Description:

Coronary ostia cannulation after TAVR