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

Coronary Artery Disease Clinical Trial

— RE-ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026204
• Other study ID #: UCatania001
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: September 2020
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 1, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Coronary Artery Disease

Locations

Country	Name	City	State
Italy	Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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