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

NCT00346515 | Completed DMC

• 1 other identifier: 864
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

Multicenter, prospective, feasibility 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 using the Guidant Acculink carotid stent in high surgical risk patients.

Conditions

Carotid Artery Stenosis

Keywords

carotid artery; carotid stenosis; carotid stenting; embolic protection

Outcome Measures

Primary Outcomes (1)

• The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.

Secondary Outcomes (1)

• All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates

Interventions

FiberNet Emboli Protection System DEVICE

Eligibility Criteria

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

You may qualify if:

• One or more of the high surgical risk 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.

You may not qualify if:

• Allergy to Heparin.
• Myocardial infarction within the last 14 days.
• Angioplasty or PTCA/PTA procedure within the past 48 hours.
• Cardiac surgery within the past 60 days.
• Planned invasive surgical procedure within 30 days.
• Stroke within the past 14 days.
• Transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
• Intracranial stenosis that exceeded the severity of an extracranial stenosis.
• Peripheral vascular disease of sufficient severity to prevent vascular access to the target lesion.
• Total occlusion of the target vessel.
• Lesion within 2cm 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')

Sponsors & Collaborators

• Lumen Biomedical: lead

Study Sites (4)

Hoag Hospital

Newport Beach, California, 92658, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

North Central Heart Institue

Sioux Falls, South Dakota, 57108, United States

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

• J. Michael Bacharach, MD

  North Central Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: June 1, 2006
• Study Completion: January 1, 2008
• Last Updated: October 21, 2008

Record last verified: 2008-10

Locations

US (4)