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

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309803
• Other study ID #: 872
• Status: Completed
• Phase: N/A
• First received: March 30, 2006
• Last updated: October 20, 2008
• Start date: March 2006

Study information

• Verified date: October 2008
• Source: Lumen Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Device:
• FiberNet Embolic Protection Device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lumen Biomedical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the rate of all death and stroke within 30 days of the procedure.
Secondary	All death, stroke, and myocardial infarction rates; Non-stroke neurological event rates
Secondary	Technical success rates; Procedural success rates; Access site complication rates