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

NCT07276711 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

DEVICE

EmStop Embolic Protection System

EmStop Embolic Protection System used during TAVR procedure

DEVICE

Boston Scientific Sentinel

Sentinel device used during TAVR procedure

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • EmStop Inc

    lead INDUSTRY

Principal Investigators

  • Stanley J Chetcuti, MD · University of Michigan Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276711 on ClinicalTrials.gov