NCT00309803

EPIC European Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting

Evaluating the Use of the FiberNet® Embolic Protection Device in Carotid Artery Stenting: The EPIC European Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Lumen Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, prospective, study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The primary endpoint is the rate of all stoke and death within 30 days of the procedure.

Detailed description

The purpose of this feasibility study is to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention. The feasibility study will involve a maximum of 50 subjects to be enrolled using the FiberNet® during clinically indicated percutaneous intervention of the carotid artery and followed through 30 days post procedure. Subject will be enrolled in up to 5 European Investigational Sites. The study is a prospective multi-center registry with sequential enrollment of qualified subjects who consent to participate and meet all entrance criteria.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	FiberNet Embolic Protection Device

Timeline

• Start date: 2006-03-01
• First posted: 2006-04-03
• Last updated: 2008-10-21

Locations

3 sites across 1 country: Germany