Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
Phase 1
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00233766
- Lead Sponsor
- Cordis Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Male or non-pregnant female patient minimum 18 years of age
- 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;
- Target lesion is 18mm in length (visual estimate);
- Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
- Target lesion stenosis is >50% and <100% (visual estimate);
Exclusion Criteria
- 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;
- Ejection fraction 30%;
- Stent placement of target lesion covers a side branch >2.0mm in diameter;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Late loss measured by quantitative coronary angiography 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Instituto Dante Pazzanese de Cardiologia
🇧🇷Sao Paolo, Brazil