NCT07276711

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

Controlled Arterial Protection to Ultimately Remove Embolic Material

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 663 (estimated)
• Sponsor: EmStop Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Valve Stenosis
• Aortic Stenosis
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	EmStop Embolic Protection System	EmStop Embolic Protection System used during TAVR procedure
DEVICE	Boston Scientific Sentinel	Sentinel device used during TAVR procedure

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-07-01
• Completion: 2027-11-01
• First posted: 2025-12-11
• Last updated: 2026-01-30

Regulatory

• FDA-regulated device study