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OpenTrials
Completed

NCT Number: NCT04026204

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 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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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele

Catania, 95123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR

    Time frame: 5 minutes

    Angiographic assessment of coronary ostia selective cannulation after TAVR

Secondary outcomes

  1. Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR

    Time frame: 5 minutes

    Aortic root CTA measurements and prosthesis implantation-related factors associated with inability to selectively cannulate coronary ostia after TAVR at multivariate regression analysis

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Acronym: RE-ACCESS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2019
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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