EPIC US Pivotal Study

This study has been completed.
Sponsor:
Information provided by:
Lumen Biomedical
ClinicalTrials.gov Identifier:
NCT00460187
First received: April 11, 2007
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in high surgical risk patients.


Condition Intervention
Percutaneous Intervention of the Carotid Arteries.
Device: Percutaneous intervention of the carotid artery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.

Resource links provided by NLM:


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:
  • Secondary Endpoints are: all death and all stroke rates, non-stroke neurological event rates, technical success rates, procedural success rates, and access site complication rates.

Enrollment: 237
Study Start Date: March 2007
Study Completion Date: June 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.
  • Symptomatic with atherosclerotic stenosis ≥ 50% or asymptomatic with atherosclerotic stenosis ≥ 70% of the carotid artery by NASCET Criteria.

Exclusion Criteria:

  • 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.
  • Suffered a stroke within the past 14 days.
  • Suffered a transient ischemic neurological attack (TIA) or amaurosis fugax within the past 48 hours.
  • Abnormal baseline blood counts; platelets <50,000 or >700,000/mm3 or WBC count < 3 x103/uL.
  • Intracranial stenosis that exceeded the severity of an extracranial stenosis.
  • 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
  • Serial lesions that requires more than one stent to cover entire lesion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460187

Locations
United States, California
Hoag Hospital
Newport Beach, California, United States, 92663
United States, South Dakota
Heart Hospital of South Dakota
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Lumen Biomedical
Investigators
Principal Investigator: J. Michael Bacharach, MD Heart Hospital of South Dakota
Principal Investigator: Subbarao Mylavarapu, MD Hoag Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00460187     History of Changes
Other Study ID Numbers: 90-1145
Study First Received: April 11, 2007
Last Updated: October 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Lumen Biomedical:
carotid artery, distal protection device, carotid stenting

ClinicalTrials.gov processed this record on July 24, 2014