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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00225680 |
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Date of registration:
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12/09/2005 |
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Primary sponsor: |
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Public title:
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In Stent ELUTES Study
ELUTES II |
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Scientific title:
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ELUTES II - In Stent ELUTES Study |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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124 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00225680 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ivan DeScheerder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Gathuisberg |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Device: drug eluting coronary stent
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Primary Outcome(s)
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Angiographic target vessel failure (TVF) at follow up
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Secondary Outcome(s)
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Major adverse events
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Target lesion revascularization
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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