- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00225680
In Stent ELUTES Study (ELUTES II)
January 30, 2012 updated by: Cook Group Incorporated
ELUTES II - In Stent ELUTES Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
124
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
-
-
Indiana
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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 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.
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 |
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Angiographic target vessel failure (TVF) at follow up
|
Secondary Outcome Measures
Outcome Measure |
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Major adverse events
|
Target lesion revascularization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ivan DeScheerder, MD, University Hospital of Gathuisberg
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
April 1, 2002
Study Completion
August 1, 2005
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
- 524
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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