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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-02-01

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.

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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.

Conditions

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Aortic Stenosis Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary cannulation after TAVR

Coronary ostia cannulation after TAVR

No interventions assigned to this group

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No