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出境医 / 临床实验 / Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS) (RE-ACCESS)
Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS) (RE-ACCESS)
Study Description
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.
| Condition or disease |
|---|
| Aortic Stenosis Coronary Artery Disease |
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 Design
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 300 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 1 Month |
| Official Title: | Prospective, Observational, Single Center Trial of Reobtaining Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS) |
| Actual Study Start Date : | December 1, 2018 |
| Actual Primary Completion Date : | January 31, 2020 |
| Actual Study Completion Date : | February 1, 2020 |
Arms and Interventions
| Group/Cohort |
|---|
|
Coronary cannulation after TAVR
Coronary ostia cannulation after TAVR
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with symptomatic, severe aortic stenosis who underwent TAVR
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
Contacts and Locations
Locations
| Italy | |
| Department of Cardiology, CAST, AU Policlinico-Vittorio Emanuele | |
| Catania, Italy, 95123 | |
Sponsors and Collaborators
University of Catania
Investigators
| Principal Investigator: | Marco Barbanti, MD | University of Catania |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 12, 2019 | ||||
| First Posted Date | July 19, 2019 | ||||
| Last Update Posted Date | September 7, 2020 | ||||
| Actual Study Start Date | December 1, 2018 | ||||
| Actual Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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) | ||||
| 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. |
||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 1 Month | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with symptomatic, severe aortic stenosis who underwent TAVR | ||||
| Condition |
|
||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Coronary cannulation after TAVR
Coronary ostia cannulation after TAVR
|
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| 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | February 1, 2020 | ||||
| Actual Primary Completion Date | January 31, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04026204 | ||||
| Other Study ID Numbers | UCatania001 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Marco Barbanti, University of Catania | ||||
| Study Sponsor | University of Catania | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | University of Catania | ||||
| Verification Date | September 2020 | ||||
