Coronary Artery Disease
Conditions
Brief summary
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.
Interventions
DEVICEBx VELOCITY Stent containing 45% and 70% of Sirolimus dose
Sponsors
Cordis US Corp.
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
1. Male or non-pregnant female patient minimum 18 years of age 2. No significant (\>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff; 3. Target lesion is 18mm in length (visual estimate); 4. Target lesion is 3.0mm and 3.5mm in diameter (visual estimate); 5. Target lesion stenosis is \>50% and \<100% (visual estimate);
Exclusion criteria
1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; 2. Ejection fraction 30%; 3. Stent placement of target lesion covers a side branch \>2.0mm in diameter;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure. | four-months and twelve-months post-procedure |
| NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure. | four-months and twelve-months post-procedure |
| Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure. | four-months and twelve months post-procedure |
| Four and twelve month target vessel failure (TVF). | Four and twelve month |
Countries
Brazil
Outcome results
None listed