- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04026204
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS) (RE-ACCESS)
Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Catania, Italy, 95123
- Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Coronary cannulation after TAVR
Coronary ostia cannulation after TAVR
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients in whom it was possible to selectively cannulate coronary ostia after TAVR
Time Frame: 5 minutes
|
Angiographic assessment of coronary ostia selective cannulation after TAVR
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hazard ratios of factors associated with the inability to selectively cannulate coronary ostia after TAVR
Time Frame: 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
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Barbanti, MD, University of Catania
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCatania001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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