Actively Recruiting
Controlled Arterial Protection to Ultimately Remove Embolic Material during TAVR Procedures
Led by EmStop Inc · Updated on 2026-05-19
663
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
EmStop Inc
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the EmStop Embolic Protection System during self-expanding transcatheter aortic valve replacement (TAVR) procedures in patients with severe aortic valve stenosis. This prospective, single-blind, multi-center, randomized study compares the EmStop device to the Boston Scientific Sentinel device, with participants followed for 30 days after the TAVR procedure. The purpose is to demonstrate that the EmStop device is not worse than the Sentinel device in capturing and removing thrombus or debris during the procedure. Participants will be randomly assigned in a 2:1 ratio to receive either the EmStop Embolic Protection System or the Sentinel device during their TAVR procedure. The study requires specific anatomical compatibility confirmed by imaging, including echocardiogram and computed tomography angiography (CTA) scans, to ensure proper device positioning. Procedures must be performed Monday through Thursday to allow for neurological assessments. The trial is conducted at up to 25 U.S. sites and involves careful monitoring of device performance during the procedure. During the study, participants will undergo pre-procedure imaging tests like echocardiograms and CTA scans to confirm eligibility. They will be monitored for up to 30 days after the TAVR procedure to assess major adverse cardiac and cerebrovascular events (MACCE) and the ability of the devices to capture debris. Neurological assessments and other clinical evaluations will be performed, with adherence to protocol-specified procedures and follow-up visits. The total study participation spans from consent through 30 days post-procedure, ensuring thorough safety and efficacy evaluation.
CONDITIONS
Brief Title
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older at the time of consent
- Meets FDA-approved indications for elective transfemoral self-expanding TAVR on native or valve-in-valve aortic valve
- Left ventricular ejection fraction of 30% or higher confirmed by echocardiogram
- Willing and able to provide written informed consent and HIPAA authorization
- Willing and able to comply with protocol procedures and assessments
- Echocardiogram within 6 months before procedure confirming left ventricular ejection fraction ≥ 30%
- Computed tomography angiography (CTA) within 6 months before procedure confirming anatomical compatibility with study devices
- Procedure performed Monday through Thursday due to neurological assessment requirements
- Anatomical criteria for EmStop device: ascending aorta length ≥ 8 cm, femoral and iliac artery lumen diameter ≥ 8.0 mm, ascending aorta/aortic arch diameter 25–40 mm, limited atheromatous disease and wall calcification (≤ Grade 1)
- Anatomical criteria for Sentinel device: brachiocephalic artery diameter 9–15 mm, left common carotid artery diameter 6.5–10 mm, arterial stenosis < 70%, no significant artery abnormalities near aortic ostium, adequate blood flow to right upper extremity, and access vessels without excessive tortuosity
You will not qualify if you...
- Use of balloon-expandable transcatheter aortic valve for the procedure
- History of stroke or transient ischemic attack within 6 months or prior stroke with major disability (NIHSS >1 at baseline)
- Left ventricular ejection fraction below 30%, cardiogenic shock, or hypotension requiring inotropes or mechanical support within 3 months prior
- Acute myocardial infarction within 30 days before procedure
- Planned other open cardiac surgery or left heart intervention during or within 30 days before TAVR
- Renal failure with estimated glomerular filtration rate below 30 mL/min
- Uncorrectable hypercoagulable state
- Intolerance or allergy to study medications including heparin, aspirin, clopidogrel, contrast media, or anesthesia
- Undergoing therapeutic thrombolysis
- History of bleeding disorders or major coagulopathy
- Hepatic failure (Child-Pugh class C)
- Active endocarditis or systemic infection with fever >38°C or high white blood cell count
- Known allergy to EmStop system materials (e.g., nitinol)
- Participation in another drug or device clinical study
- Known or suspected pregnancy or lactation; women of childbearing potential require negative pregnancy test within 48 hours prior
- Vulnerable populations such as incarcerated or cognitively challenged adults
- Any other clinical reason making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo a TAVR procedure during which they are randomized to receive either the EmStop Embolic Protection System or the Sentinel device to protect against embolic material.
1 procedure visit (in-person)
Duration - 30 days
Participants are followed for 30 days after the TAVR procedure to monitor safety and device effectiveness.
Follow-up visits as scheduled up to 30 days post-procedure
Trial Site Locations
Total: 2 locations
1
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Actively Recruiting
2
Mission Health
Asheville, North Carolina, United States, 28801
Actively Recruiting
Research Team
K
Katherine Vo
D
Danielle Gustasfon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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