Clinical trial NCT00346515: EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
Official title: Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Stenosis
Keywords: carotid artery
carotid stenosis
carotid stenting
embolic protection
Lead sponsor: Lumen Biomedical
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
Secondary outcomes:
measure: All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Sioux Falls
country: United States
facility: North Central Heart Institue
state: South Dakota
Study officials:
affiliation: North Central Heart Institute
name: J. Michael Bacharach, MD
role: PRINCIPAL_INVESTIGATOR
References: