EPIC US Pivotal Study (EPIC)

October 20, 2008 updated by: Lumen Biomedical

Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting: The EPIC US Pivotal Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Heart Hospital of South Dakota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The rate of all death, all stroke and myocardial infarction within 30 days of the procedure.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumen Biomedical

Investigators

  • Principal Investigator: J. Michael Bacharach, MD, Heart Hospital of South Dakota
  • Principal Investigator: Subbarao Mylavarapu, MD, Hoag Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 20, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 90-1145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Percutaneous Intervention of the Carotid Arteries.

Clinical Trials on Percutaneous intervention of the carotid artery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe