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The ELUTES Clinical Trial (ELUTES I)

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: NCT00225654
Recruitment Status : Completed
First Posted : September 26, 2005
Last Update Posted : February 1, 2012
Sponsor:
Information provided by:
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: coronary stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The ELUTES Clinical Trial (European Evaluation of Paclitaxel Eluting Stent)
Study Start Date : January 2000
Study Completion Date : November 2001



Primary Outcome Measures :
  1. Angiographic in-stent % diameter stenosis and late loss at follow up.

Secondary Outcome Measures :
  1. Major adverse events
  2. Total lesion revascularization


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00225654


Locations
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United States, Indiana
Contact Sponsor
Bloomington, Indiana, United States
Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: Anthony Gershlick, MD Glenfield Hospital

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ClinicalTrials.gov Identifier: NCT00225654    
Other Study ID Numbers: 505
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012
Keywords provided by Cook Group Incorporated:
coronary artery
stent
drug eluting
patency
restenosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases