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In Stent ELUTES Study (ELUTES II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225680
First Posted: September 26, 2005
Last Update Posted: February 1, 2012
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:
Cook Group Incorporated
  Purpose
This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.

Condition Intervention
Coronary Artery Disease Device: drug eluting coronary stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: ELUTES II - In Stent ELUTES Study

Further study details as provided by Cook Group Incorporated:

Primary Outcome Measures:
  • Angiographic target vessel failure (TVF) at follow up

Secondary Outcome Measures:
  • Major adverse events
  • Target lesion revascularization

Estimated Enrollment: 124
Study Start Date: April 2002
Estimated Study Completion Date: August 2005
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient has given informed consent
  • Patient has target lesion in native coronary artery or coronary bypass graft
  • Patient has in-stent restenosis >60%
  • Patient has reference artery diameter 2.7-3.5
  • Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

Exclusion Criteria:

  • Patient is less than 18 years of age
  • Patient is pregnant or breast feeding
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
  • Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.
  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): NCT00225680


Locations
United States, Indiana
Contact Sponsor
Bloomington, Indiana, United States
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Ivan DeScheerder, MD University Hospital of Gathuisberg
  More Information

ClinicalTrials.gov Identifier: NCT00225680     History of Changes
Other Study ID Numbers: 524
First Submitted: September 12, 2005
First Posted: September 26, 2005
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases