Aortic Valve StenosisNCT07276711
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
A study testing EmStop Embolic Protection System and Boston Scientific Sentinel in people with Aortic Valve Stenosis and Aortic Stenosis, run by EmStop Inc at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- What is being tested?
- EmStop Embolic Protection System and Boston Scientific Sentinel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 663 participants
- Where
- 7 sitesUnited States
- Study dates
- 12 May 2026to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
- Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale [NIHSS] >1 at baseline)
- Left ventricular ejection fraction <30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure
- Acute myocardial infarction (MI) within 30 days of the planned index procedure
- Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.
- Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
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- Hypercoagulable state that cannot be corrected by additional periprocedural heparin
- History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated
- Undergoing therapeutic thrombolysis
- History of bleeding diathesis or major coagulopathy
- Hepatic failure (Child-Pugh class C)
- Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or WBC >15,000 IU
- Known allergy to any materials used in the EmStop system (e.g., nitinol)
- Currently participating in another drug or device clinical study
- Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Michigan Health | Michigan Medicine
Ann Arbor, Michigan, 48109
Paul M Grossman, MD
- Recruiting
Mission Health
Asheville, North Carolina, 28801
Michaeal Chenier, MD
- Recruiting
Morton Plant Hospital | BayCare Health
Clearwater, Florida, 33756
Joshua Rovin, MD
- Recruiting
Ochsner Medical Center
New Orleans, Louisiana, 70121
James S Jenkins, MD
- Recruiting
Monument Health Heart and Vascular Institute
Rapid City, South Dakota, 57701
Joseph Tuma, MD
- Recruiting
Methodist Research Institute
San Antonio, Texas, 78229
Jorge Alvarez, MD
- Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Saibal Kar, MD
About this study
Official title: Controlled Arterial Protection to Ultimately Remove Embolic Material
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.
Read the detailed description
This is a prospective, single-blind, multi-center, randomized study conducted in up to 25 U.S. investigational sites. Subjects with severe aortic valve stenosis (AS) will be randomized 2:1 to the EmStop Embolic Protection System (study device) versus the Sentinel device (control group) and followed to 30 days post TAVR procedure.
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Being tested
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Keywords
- Transcatheter aortic valve replacement (TAVR), Cerebral embolic protection device, Stroke, Cerebrovascular accident, Neuroprotection, Aortic valve disease, Aortic valve stenosis, Aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmStop Embolic Protection SystemDevice
EmStop Embolic Protection System used during TAVR procedure
Boston Scientific SentinelDevice
Sentinel device used during TAVR procedure
| Study group | Role | What they receive |
|---|---|---|
| EmStop System | Experimental | Not described Receives: Device: EmStop Embolic Protection System |
| Boston Scientific Sentinel device | Active comparator | Not described Receives: Device: Boston Scientific Sentinel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Inferiority
Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days
Measured: Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate
Secondary outcomes (2)
Non-Inferiority
Hypothesis-driven secondary efficacy endpoint is the composite rate through 30-days post-procedure of NeuroARC defined ischemic embolic stroke, VARC-3 defined AKI, and systemic embolization
Measured: 30 days
Debris Capture
Hypothesis-driven secondary efficacy endpoint is the total debris capture, defined as the number of captured particles of at least ≥ 150micron
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start12 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 663 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EmStop Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Stanley J Chetcuti, MD, Principal investigator, University of Michigan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276711
- Sponsor's protocol ID
- EMS-CL-5100
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No