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

NCT ID: NCT00309803

Last Updated: 2008-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31

Brief 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

Keywords

Carotid artery; distal protection device

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

FiberNet Embolic Protection Device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Candidate for percutaneous stenting with target lesion located within common or internal carotid artery.
• Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.
• Targeted vessel diameter for FiberNet placement between 1.75 mm and 7.0 mm.
• The investigator determines that all branch vessels distal to the target lesion and proximal to the proposed site of device deployment will be adequately protected.

Exclusion Criteria

• Prior stenting of ipsilateral carotid.
• Planned treatment of contralateral carotid within 30 days.
• Experienced a myocardial infarction within the last 14 days.
• Undergone an angioplasty or PTCA/PTA procedure within the past 48 hours.
• Undergone cardiac surgery within the past 60 days.
• Has a planned invasive surgical procedure within 30 days.
• Suffered a stroke within the past 14 days.
• Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
• Total occlusion of the target vessel.
• Lesions within 2 cm of the ostium of the common carotid artery.
• A stenosis that is known to be unsuitable for stenting because of one or more of: Tortuous or calcified anatomy proximal or distal to the stenosis, Presence of visual thrombus, Pseudo occlusion (string sign).
• Serial lesions that requires more then one stent to cover entire lesion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumen Biomedical

INDUSTRY

Sponsor Role: lead

Principal Investigators

Joachim Schofer, Prof. med.

Role: PRINCIPAL_INVESTIGATOR

Andreas-Gruntzig-Haus

Locations

Dortmund, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Countries

Germany

Other Identifiers

872

Identifier Type: -

Identifier Source: org_study_id