Status:
COMPLETED
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Deliver...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00233766
Start Date
September 1 2002
End Date
December 1 2007
Last Update
April 24 2008
Active Locations (1)
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1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil