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

August 25, 2026 updated by: EmStop Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
663

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Regional Medical Center
        • Principal Investigator:
          • Saibal Kar, MD
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant Hospital | BayCare Health
        • Principal Investigator:
          • Joshua Rovin, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
        • Principal Investigator:
          • James S Jenkins, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health | Michigan Medicine
        • Principal Investigator:
          • Paul M Grossman, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Mission Health
        • Principal Investigator:
          • Michaeal Chenier, MD
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Monument Health Heart and Vascular Institute
        • Principal Investigator:
          • Joseph Tuma, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Research Institute
        • Principal Investigator:
          • Jorge Alvarez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Non-Inferiority
Time Frame: Non-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
Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-Inferiority
Time Frame: 30 days
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
Time Frame: 30 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EmStop Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bright Research Partners

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stanley J Chetcuti, MD, University of Michigan Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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