Clinical trial NCT04026204: Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
Official title: Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Coronary Artery Disease
Keywords: TAVR
Coronary cannulation
Transcatheter aortic prosthesis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic, severe aortic stenosis who underwent TAVR

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
timeFrame: 5 minutes
Secondary outcomes:
measure: Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele
Study officials:
affiliation: University of Catania
name: Marco Barbanti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.