CompletedNCT04026204RE-ACCESSUpdated Sep 7, 2020

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

An observational study in Aortic Stenosis and Coronary Artery Disease, sponsored by University of Catania. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2020-09-07.

Sponsored by University of Catania · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 300
Sex: All

Study 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.

Read the 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.

Conditions studied

Aortic Stenosis
Coronary Artery Disease

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Keywords

TAVR
Coronary cannulation
Transcatheter aortic prosthesis

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 300 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Catania is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients with symptomatic, severe aortic stenosis who underwent TAVR

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

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 300 participants (actual)
Target follow-up: 1 Month
Patient registry: Yes

Groups and cohorts

Coronary cannulation after TAVR
Coronary ostia cannulation after TAVR

What researchers measure

Primary outcomes

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

Secondary outcomes

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
Time frame: 5 minutes

Study locations

1 site

Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele
Catania, 95123, Italy

References and documents

Publications

Barbanti M, Costa G, Picci A, Criscione E, Reddavid C, Valvo R, Todaro D, Deste W, Condorelli A, Scalia M, Licciardello A, Politi G, De Luca G, Strazzieri O, Motta S, Garretto V, Veroux P, Giaquinta A, Giuffrida A, Sgroi C, Leon MB, Webb JG, Tamburino C. Coronary Cannulation After Transcatheter Aortic Valve Replacement: The RE-ACCESS Study. JACC Cardiovasc Interv. 2020 Nov 9;13(21):2542-2555. doi: 10.1016/j.jcin.2020.07.006. Epub 2020 Oct 14. PubMed 33069648 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04026204
Lead sponsor: University of Catania
Responsible party: Marco Barbanti (Principal Investigator, University of Catania) — Principal investigator
First posted: Jul 19, 2019
Start date: Dec 1, 2018
Primary completion: Jan 31, 2020
Completion: Feb 1, 2020
Last update: Sep 7, 2020

Study contacts

Marco Barbanti, MD

principal investigator · University of Catania

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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