Status:
COMPLETED
Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to si...
Eligibility Criteria
Inclusion
- The patient must be minimum 18 years of age;
- Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
- Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
- The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
- The target lesion is \<30 mm in length (visual estimate) located in a native coronary artery;
- Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);
Exclusion
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK\>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
- Patients admitted for treatment of diabetic ketoacidosis \> 2 times in the past six months (Brittle Diabetics);
- Ejection fraction 30%;
- Impaired renal function (creatinine \> 2.0 mg/dL);
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00233714
Start Date
May 1 2003
End Date
November 1 2009
Last Update
November 19 2009
Active Locations (1)
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1
Institute Dante Pazzanese of Cardiology
São Paulo, Brazil