Back to resultsRandomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE)
Primary Purpose
Aortic Valve Stenosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Manta
ProGlide
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Vascular access site closure, Transcatheter aortic valve implantation, Vascular closure device, Vascular access-site injury
Eligibility Criteria
Inclusion Criteria:
- Patients with an indication for transfemoral TAVI as judged by the local heart team.
- Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
- The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
Exclusion Criteria:
- Vascular access site anatomy not suitable for percutaneous vascular closure.
- Vascular access site complications prior to the TAVI procedure.
- Known allergy or hypersensitivity to any VCD component.
- Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
- Absence of computed tomographic data of the access site before the procedure.
- Systemic infection or a local infection at or near the access site.
- Life expectancy of less than 6 months due to non-cardiac conditions.
- Patient cannot adhere to or complete the investigational protocol for any reason.
- Pregnant or nursing subjects.
- Participation in any other interventional trial.
Sites / Locations
- Herzzentrum Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Manta
ProGlide
Arm Description
plug-based vascular closure
suture-based vascular closure
Outcomes
Primary Outcome Measures
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Secondary Outcome Measures
Rate of access-site or access-related vascular injury
Rate of access-site or access-related vascular injury
Rate of major access-site or access-related vascular injury
Rate of major access-site or access-related vascular injury
Rate of minor access site or access-related vascular injury
Rate of minor access site or access-related vascular injury
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
all-cause death
all-cause death
death attributed to access-site or access-related complications
death attributed to access-site or access-related complications
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other
access-site or access-related disabling/life- threatening bleeding according to BARC
access-site or access-related disabling/life- threatening bleeding according to BARC
access-site or access-related major bleeding according to BARC
access-site or access-related major bleeding according to BARC
access-site or access-related minor bleeding according to BARC
access-site or access-related minor bleeding according to BARC
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Total number of blood transfusions because of access-site or access-related bleeding
Total number of blood transfusions because of access-site or access-related bleeding
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Length of postprocedural hospital stay
Length of postprocedural hospital stay
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Need and number of additional unplanned VCDs
Need and number of additional unplanned VCDs
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Full Information
NCT ID
NCT04459208
First Posted
June 26, 2020
Last Updated
September 28, 2021
Sponsor
Helios Health Institute GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04459208
Brief Title
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Acronym
CHOICE-CLOSURE
Official Title
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helios Health Institute GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the clinical efficacy of 2 different vascular closure device (VCD) strategies during transfemoral transcatheter aortic valve implantation (TAVI). The study hypothesizes that the choice of one over the other VCD in patients undergoing transfemoral TAVI may demonstrate relevant differences in the rate of peri-procedural complications and effectiveness of vascular closure.
Detailed Description
Use of a plug-based VCD in patients undergoing transfemoral TAVI as compared to a suture-based VCD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Vascular access site closure, Transcatheter aortic valve implantation, Vascular closure device, Vascular access-site injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Investigator-initiated, single-center, prospective, open-label randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
516 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manta
Arm Type
Active Comparator
Arm Description
plug-based vascular closure
Arm Title
ProGlide
Arm Type
Active Comparator
Arm Description
suture-based vascular closure
Intervention Type
Device
Intervention Name(s)
Manta
Intervention Description
plug-based vascular closure
Intervention Type
Device
Intervention Name(s)
ProGlide
Intervention Description
suture-based vascular closure
Primary Outcome Measure Information:
Title
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Description
Rate of in-hospital access-site or access-related vascular injury according to the VARC-2 definition
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Rate of access-site or access-related vascular injury
Description
Rate of access-site or access-related vascular injury
Time Frame
30 days
Title
Rate of major access-site or access-related vascular injury
Description
Rate of major access-site or access-related vascular injury
Time Frame
up to 7 days and at 30 days
Title
Rate of minor access site or access-related vascular injury
Description
Rate of minor access site or access-related vascular injury
Time Frame
up to 7 days and at 30 days
Title
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Description
Rate of access-site or access-related vascular injury, access-site or access-related bleeding and VCD failure according to VARC-2 criteria
Time Frame
up to 7 days and at 30 days)
Title
all-cause death
Description
all-cause death
Time Frame
up to 7 days and 30-day
Title
death attributed to access-site or access-related complications
Description
death attributed to access-site or access-related complications
Time Frame
up to 7 days and 30-day
Title
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
Description
Unplanned vascular surgery and / or use of endovascular stent or stent-graft or other
Time Frame
up to 7 days
Title
access-site or access-related disabling/life- threatening bleeding according to BARC
Description
access-site or access-related disabling/life- threatening bleeding according to BARC
Time Frame
up to 7 days and 30-day
Title
access-site or access-related major bleeding according to BARC
Description
access-site or access-related major bleeding according to BARC
Time Frame
up to 7 days and 30-day
Title
access-site or access-related minor bleeding according to BARC
Description
access-site or access-related minor bleeding according to BARC
Time Frame
up to 7 days and 30-day
Title
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Description
Need for blood transfusion for access-site or access-related bleeding or vascular complications
Time Frame
up to 7 days
Title
Total number of blood transfusions because of access-site or access-related bleeding
Description
Total number of blood transfusions because of access-site or access-related bleeding
Time Frame
up to 7 days
Title
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Description
Rate of vascular closure device success, defined as the ability of a closure device strategy to obtain hemostasis
Time Frame
24 hours
Title
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Description
Rate of vascular closure device failure, defined as failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment
Time Frame
24 hours
Title
Length of postprocedural hospital stay
Description
Length of postprocedural hospital stay
Time Frame
up to 7 days
Title
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Description
Time to hemostasis, defined as the time from VCD application to complete hemostasis
Time Frame
24 hours
Title
Need and number of additional unplanned VCDs
Description
Need and number of additional unplanned VCDs
Time Frame
24 hours
Title
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Description
Percent diameter stenosis of vascular access vessel on post-procedural angiography
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with an indication for transfemoral TAVI as judged by the local heart team.
Transfemoral access route and a commercially-available transcatheter aortic valve is selected by the local heart team.
The patient is willing to provide written informed consent and comply with protocol- specified follow-up evaluations.
Exclusion Criteria:
Vascular access site anatomy not suitable for percutaneous vascular closure.
Vascular access site complications prior to the TAVI procedure.
Known allergy or hypersensitivity to any VCD component.
Unstable active bleeding/ bleeding diathesis or significant unmanageable anemia.
Absence of computed tomographic data of the access site before the procedure.
Systemic infection or a local infection at or near the access site.
Life expectancy of less than 6 months due to non-cardiac conditions.
Patient cannot adhere to or complete the investigational protocol for any reason.
Pregnant or nursing subjects.
Participation in any other interventional trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel-Wahab, PD Dr.
Organizational Affiliation
Herzzentrum Leipzig GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34738828
Citation
Abdel-Wahab M, Hartung P, Dumpies O, Obradovic D, Wilde J, Majunke N, Boekstegers P, Muller R, Seyfarth M, Vorpahl M, Kiefer P, Noack T, Leontyev S, Sandri M, Rotta Detto Loria J, Kitamura M, Borger MA, Funkat AK, Hohenstein S, Desch S, Holzhey D, Thiele H; CHOICE-CLOSURE Investigators. Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial. Circulation. 2022 Jan 18;145(3):170-183. doi: 10.1161/CIRCULATIONAHA.121.057856. Epub 2021 Nov 5.
Results Reference
derived
Learn more about this trial
Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation
We'll reach out to this number within 24 hrs