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CAPTURE-2 Study for Aortic Valve Stenosis

This study, called CAPTURE-2, is looking at how safe and effective the EmStop Embolic Protection System is when used during a TAVR procedure. TAVR (Transcatheter Aortic Valve Replacement) is a way to replace a narrowed aortic valve without open-heart surgery. The EmStop device is designed to catch and remove small pieces of debris that might break off during the procedure. Researchers want to see if the EmStop device is at least as good as another device, the Boston Scientific Sentinel, at preventing serious problems like stroke. You might be able to join if you are at least 22 years old and need a TAVR procedure for severe aortic valve stenosis (a narrowing of the heart's main valve). The study is currently recruiting participants.

Study design
This is a randomized study where participants will be assigned by chance to receive either the EmStop Embolic Protection System or the Boston Scientific Sentinel device during their TAVR procedure. About 663 people are expected to join this study across multiple centers in the U.S.
What's involved
Participants will undergo a TAVR procedure with one of the study devices. Procedures must be performed Monday-Thursday due to the need for neurological assessments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 30 days after their TAVR procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276711

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material

Recruiting
NAAges 22+InterventionalTreatment
EmStop Inc
~663 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:EmStop Embolic Protection SystemBoston Scientific Sentinel

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Non-Inferiority
Measured over Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate

Conditions

Aortic Valve Stenosis
Aortic Stenosis
Aortic Valve Disease

Explore related trials

Aortic Valve Stenosis

Where it's being run

7 sites across 7 states
California1
Florida1
Louisiana1
Michigan1
North Carolina1
South Dakota1
Texas1

Study leadership

  • Stanley J Chetcuti, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Health

Who to contact

Katherine Vo
[email protected]
763-227-9954
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ascending aorta length ≥8 cm
Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm
Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm.
Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification
Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery
Arterial stenosis \<70% in either the left common carotid artery or the brachiocephalic artery
Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
Adequate blood flow to the right upper extremity
Access vessels without excessive tortuosity

What this trial measures

  • Non-InferiorityNon-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate

    Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days