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In Stent ELUTES Study (ELUTES II)

This study has been completed.
Sponsor:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00225680
First received: September 12, 2005
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: ELUTES II - In Stent ELUTES Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225680

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

No publications provided

ClinicalTrials.gov Identifier: NCT00225680     History of Changes
Other Study ID Numbers: 524
Study First Received: September 12, 2005
Last Updated: January 30, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cook:
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

ClinicalTrials.gov processed this record on May 23, 2013