Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT04026204
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
Sponsor:
University of Catania
Organization:
Study Overview
Official Title:
Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-ACCESS
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: