Coronary Artery Disease
Conditions
Keywords
coronary artery, restenosis, patency, drug eluting, stent
Brief summary
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.
Interventions
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery. * Patient must be an acceptable candidate for coronary artery bypass surgery * Patient or legal guardian must have given informed consent * Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.
Exclusion criteria
* Patient must be less than 18 years old * Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. * Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study. * Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye. * Women of child bearing potential. * Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation by IVUS of % diameter stenosis at follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse events | — |
| Target lesion revascularization | — |
Countries
United States
Outcome results
None listed