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Controlled Arterial Protection to Ultimately Remove Embolic Material

NCT06103591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-29

Study results available
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Summary

The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

The EmStop Embolic Protection System (EmStop System)

The EmStop Embolic Protection System (EmStop System) is a catheter-based filter system that captures and removes debris dislodged during transcatheter aortic valve replacement (TAVR) procedures.

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • EmStop Inc

    lead INDUSTRY

Principal Investigators

  • Emily Vollbrecht · Bright Research Partners

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2024-09-04
Completion
2024-10-14
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 NCT06103591 on ClinicalTrials.gov