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

NCT00309803 | Completed

• 1 other identifier: 872
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Carotid Artery Stenosis

Keywords

Carotid artery; distal protection device

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the rate of all death and stroke within 30 days of the procedure.

Secondary Outcomes (2)

• All death, stroke, and myocardial infarction rates; Non-stroke neurological event rates

• Technical success rates; Procedural success rates; Access site complication rates

Interventions

FiberNet Embolic Protection Device DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumen Biomedical: lead

Study Sites (3)

Unknown Facility

Dortmund, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Hamburg, Germany

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joachim Schofer, Prof. med.

  Andreas-Gruntzig-Haus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 30, 2006
• First Posted: April 3, 2006
• Study Start: March 1, 2006
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

DE (3)