Coronary Artery Disease
Conditions
Keywords
coronary artery, stent, drug eluting, patency, restenosis
Brief summary
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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic target vessel failure (TVF) at follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse events | — |
| Target lesion revascularization | — |
Countries
United States
Outcome results
None listed