RecruitingNCT07276711
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
AI Description
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.
- Who can join
- adult, older adult
- Participants
- 663
- Expected completion
- 2028-05
- Funded by
- industry
Conditions studied
Aortic Stenosis, Aortic Valve Disease, Aortic Valve Stenosis
What is being tested
- DEVICE: Boston Scientific Sentinel
- DEVICE: EmStop Embolic Protection System
What it measures
- Non-Inferiority, Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days, Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate
Working with
Bright Research Partners
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Los Robles Regional Medical Center
Thousand Oaks, CA
Methodist Hospital
San Antonio, TX
Mission Hospital (Asheville)
Asheville, NC
Monument Health Rapid City Hospital
Rapid City, SD
Morton Plant Hospital (Clearwater)
Clearwater, FL
Ochsner Medical Center – New Orleans
New Orleans, LA
University of Michigan Health System
Ann Arbor, MI
Registry entry updated 2026-08-26
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.