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

NCT07276711 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: EMS-CL-5100
• Study Type: interventional
• Target: 663
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aortic Valve Stenosis; Aortic Stenosis; Aortic Valve Disease

Keywords

Transcatheter aortic valve replacement (TAVR); Cerebral embolic protection device; Stroke; Cerebrovascular accident; Neuroprotection; Aortic valve disease; Aortic valve stenosis; Aortic stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Non-Inferiority

  30 days

• Debris Capture

  30 days

Study Arms (2)

EmStop System

EXPERIMENTAL

Device: EmStop Embolic Protection System

Boston Scientific Sentinel device

ACTIVE COMPARATOR

Device: Boston Scientific Sentinel

Interventions

EmStop Embolic Protection System DEVICE

EmStop Embolic Protection System used during TAVR procedure

EmStop System

Boston Scientific Sentinel DEVICE

Sentinel device used during TAVR procedure

Boston Scientific Sentinel device

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 22 years at the time of consent
• Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.
• Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram
• Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
• Willing and able to comply with the protocol-specified procedures and assessments
• Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.
• 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
• \. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:
• 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

You may not qualify if:

• 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
• Renal failure, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min
• 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)

Sponsors & Collaborators

• EmStop Inc: lead
• Bright Research Partners: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Stroke

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Stanley J Chetcuti, MD

  University of Michigan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Vo

CONTACT

763-227-9954; k.vo@emstopeps.com

Danielle Gustasfon

CONTACT

612-345-4544; danielle.gustafson@brightresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to their treatment assignment to minimize expectation and reporting bias. Procedural teams will be unblinded due to the nature of device deployment; the device is temporary and not intended for implantation. Every effort will be made to have follow-up personnel remain blinded, with those conducting the neurological assessments being most critical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 11, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share