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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Aortic Valve Stenosis; Aortic Valve Disease
• Intervention / Treatment: Device: EmStop Embolic Protection System; Device: Boston Scientific Sentinel

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.

• Study Type: Interventional
• Enrollment (Estimated): 663
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Gustasfon; Phone Number: 612-345-4544; Email: danielle.gustafson@brightresearch.com
• Study Contact Backup: Name: Katherine Vo; Phone Number: 763-227-9954; Email: k.vo@emstopeps.com

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Medical Center
      • Principal Investigator: James S Jenkins, MD
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Recruiting
      • Mission Health
      • Principal Investigator: Michaeal Chenier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Clinical Inclusion Criteria

1. Age ≥ 22 years at the time of consent
2. 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.
3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram
4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
5. Willing and able to comply with the protocol-specified procedures and assessments

Imaging Inclusion Criteria

1. 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.
2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria:

EmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:

• 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

Sentinel Angiographic (CTA) Inclusion Criteria

1. 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
• Access vessels without excessive tortuosity

Exclusion Criteria:

1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
2. 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)
3. Left ventricular ejection fraction <30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure
4. Acute myocardial infarction (MI) within 30 days of the planned index procedure
5. 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.
6. Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin
8. 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
9. Undergoing therapeutic thrombolysis
10. History of bleeding diathesis or major coagulopathy
11. Hepatic failure (Child-Pugh class C)
12. Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or WBC >15,000 IU
13. Known allergy to any materials used in the EmStop system (e.g., nitinol)
14. Currently participating in another drug or device clinical study
15. 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
16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EmStop System	Device: EmStop Embolic Protection System; EmStop Embolic Protection System used during TAVR procedure
Active Comparator: Boston Scientific Sentinel device	Device: Boston Scientific Sentinel; Sentinel device used during TAVR procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	30 days

Collaborators and Investigators

• Sponsor: EmStop Inc
• Collaborators: Bright Research Partners
• Investigators: Principal Investigator: Stanley J Chetcuti, MD, University of Michigan Health

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Neuroprotection; Aortic valve stenosis; Aortic stenosis; Cerebrovascular accident; Transcatheter aortic valve replacement (TAVR); Aortic valve disease; Cerebral embolic protection device
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Disease; Stroke; Aortic Valve Stenosis
• Other Study ID Numbers: EMS-CL-5100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes