Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

EPIC US Pivotal Study (EPIC)

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.
ClinicalTrials.gov Identifier: NCT00460187
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Lumen Biomedical

Tracking Information
First Submitted Date  ICMJE April 11, 2007
First Posted Date  ICMJE April 13, 2007
Last Update Posted Date October 21, 2008
Study Start Date  ICMJE March 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00460187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EPIC US Pivotal Study
Official Title  ICMJE Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Percutaneous Intervention of the Carotid Arteries.
Intervention  ICMJE Device: Percutaneous intervention of the carotid artery
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2008)
237
Original Enrollment  ICMJE
 (submitted: April 11, 2007)
250
Actual Study Completion Date  ICMJE June 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00460187
Other Study ID Numbers  ICMJE 90-1145
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Lumen Biomedical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J. Michael Bacharach, MD Heart Hospital of South Dakota
Principal Investigator: Subbarao Mylavarapu, MD Hoag Hospital
PRS Account Lumen Biomedical
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP