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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04026204

Acronym

RE-ACCESS

Enrollment

300

Registered

2019-07-19

Start date

2018-12-01

Completion date

2020-02-01

Last updated

2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Coronary Artery Disease

Keywords

TAVR, Coronary cannulation, Transcatheter aortic prosthesis

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR	5 minutes	Angiographic assessment of coronary ostia selective cannulation after TAVR

Secondary

Measure	Time frame	Description
Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR	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

Countries

Italy

Outcome results