NCT06103591

Controlled Arterial Protection to Ultimately Remove Embolic Material

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: EmStop Inc · Industry
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-27
• Primary completion: 2024-09-04
• Completion: 2024-10-14
• First posted: 2023-10-27
• Last updated: 2025-04-29
• Results posted: 2025-04-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study