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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)

Conditions
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Aortic Stenosis, Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary cannulation after TAVR<br>Coronary ostia cannulation after TAVR | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR | Aortic root CTA measurements and prosthesis implantation-related factors associated with inability to selectively cannulate coronary ostia after TAVR at multivariate regression analysis | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVR, Coronary cannulation, Transcatheter aortic prosthesis