EPIC US Feasibility 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® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346515
• Other study ID #: 864
• Status: Completed
• Phase: N/A
• First received: June 29, 2006
• Last updated: October 20, 2008
• Start date: June 2006
• Est. completion date: January 2008

Study information

• Verified date: October 2008
• Source: Lumen Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

1. Tortuous or calcified anatomy proximal or distal to the stenosis

2. Presence of visual thrombus

3. Pseudo occlusion ('string sign')

• Serial lesions that requires more then one stent to cover entire lesion.

• Procedural complication prior to introduction of the FiberNet device into the body.

Study Design

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

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Device:
• FiberNet Emboli Protection System

Locations

Country	Name	City	State
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Hoag Hospital	Newport Beach	California
United States	North Central Heart Institue	Sioux Falls	South Dakota
United States	Washington Adventist Hospital	Takoma Park	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Lumen Biomedical

Country where clinical trial is conducted

United States, 

Outcome

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