EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
This study has been completed.
Sponsor:
Lumen Biomedical
Information provided by:
Lumen Biomedical
ClinicalTrials.gov Identifier:
NCT00346515
First received: June 29, 2006
Last updated: October 20, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carotid Artery Stenosis |
Device: FiberNet Emboli Protection System |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Evaluating the Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting: The EPIC US Feasibility Study |
Further study details as provided by Lumen Biomedical:
Primary Outcome Measures:
- The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
Secondary Outcome Measures:
- All death and all stroke rates; Non-stroke neurological event rates; Technical success rates; Procedural success rates; Access site complication rates
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2008 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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.
- Procedural complication prior to introduction of the FiberNet device into the body.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346515
Locations
| United States, California | |
| Hoag Hospital | |
| Newport Beach, California, United States, 92658 | |
| United States, Maryland | |
| Washington Adventist Hospital | |
| Takoma Park, Maryland, United States, 20912 | |
| United States, Ohio | |
| Riverside Methodist Hospital | |
| Columbus, Ohio, United States, 43214 | |
| United States, South Dakota | |
| North Central Heart Institue | |
| Sioux Falls, South Dakota, United States, 57108 | |
Sponsors and Collaborators
Lumen Biomedical
Investigators
| Principal Investigator: | J. Michael Bacharach, MD | North Central Heart Institute |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00346515 History of Changes |
| Other Study ID Numbers: | 864 |
| Study First Received: | June 29, 2006 |
| Last Updated: | October 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Lumen Biomedical:
|
carotid artery carotid stenosis carotid stenting embolic protection |
Additional relevant MeSH terms:
|
Carotid Stenosis Constriction, Pathologic Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on June 18, 2013