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EPIC US Pivotal Study (EPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00460187
First Posted: April 13, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lumen Biomedical
  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
Intervention Model: Single Group Assignment
Masking: None (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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00460187     History of Changes
Other Study ID Numbers: 90-1145
First Submitted: April 11, 2007
First Posted: April 13, 2007
Last Update Posted: October 12, 2017
Last Verified: October 2008

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