Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials


This study has been completed.
Information provided by:
Cook Identifier:
First received: September 12, 2005
Last updated: January 30, 2012
Last verified: January 2012

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00225680

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

No publications provided 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
drug eluting

Additional relevant MeSH terms:
Coronary Artery Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases processed this record on March 03, 2015