Status:
COMPLETED
FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiog...
Detailed Description
This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mount...
Eligibility Criteria
Inclusion
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
- Single de novo or restenotic lesion requiring treatment in a major native coronary artery;
- 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;
- Unprotected left main coronary disease with \>=50% stenosis;
- Have an ostial target lesion;
- Angiographic evidence of thrombus within target lesion;
- Calcified lesions which cannot be successfully predilated;
- Ejection fraction \<=30%;
- Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
- Totally occluded vessel;
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00233792
Start Date
December 1 1999
End Date
March 1 2005
Last Update
October 12 2007
Active Locations (1)
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1
Instituto Dante Pazzanese of Cardiology
São Paulo, Brazil, 04012-909