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COMPLETEDNCT04026204

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

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 curr...

Lead sponsor: University of Catania•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Catania

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.

Age

All ages

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 7, 2020Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment300

Start dateDec 2018

Last updatedSep 7, 2020

Condition

Aortic Stenosis Coronary Artery Disease

Locations shown

Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele

Catania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 7, 2020Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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