Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)

Cordis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Coronary Artery Disease

Treatments: Device: Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233766

P02-6314

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind