The ELUTES Clinical Trial (ELUTES I)

January 30, 2012 updated by: Cook Group Incorporated

The ELUTES Clinical Trial (European Evaluation of Paclitaxel Eluting Stent)

ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronary artery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

192

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
    • Indiana
      • Bloomington, Indiana, United States
        • Contact Sponsor

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:

  • Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
  • Patient must be an acceptable candidate for coronary artery bypass surgery.
  • Patient or legal guardian must have signed informed consent.
  • Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

  • Patient must be less than 18 years old.
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
  • Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
  • Women of child bearing potential.
  • Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
  • Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Angiographic in-stent % diameter stenosis and late loss at follow up.

Secondary Outcome Measures

Outcome Measure
Major adverse events
Total lesion revascularization

Collaborators and Investigators

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

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Anthony Gershlick, MD, Glenfield Hospital

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

January 1, 2000

Study Completion

November 1, 2001

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 505

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.

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