Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions
Phase 1
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: CYPHER Sirolimus-Eluting Coronary Stent
- Registration Number
- NCT00233714
- Lead Sponsor
- Cordis Corporation
- 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 single dose sirolimus-eluting Bx VELOCITY™ stents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- 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 Criteria
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 CYPHER Sirolimus-Eluting Coronary Stent Double-dose Sirolimus-Eluting Coronary stent 1 CYPHER Sirolimus-Eluting Coronary Stent Single-dose Sirolimus-Eluting Coronary stent
- Primary Outcome Measures
Name Time Method The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. 6 months post-procedure
- Secondary Outcome Measures
Name Time Method Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. During Index Procedure Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. During Index Procedure Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay. During the hospital stay In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years. 6 months and 2 years In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years. post-procedure and at 6 months and 2 years In-lesion late lumen loss measured by QCA at 6 months and 2 years. 6 months and 2 years Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years. post-procedure 6 months and 2 years. Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months. baseline, 6, 12, and 24 months C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes. baseline, 6, 12, and 24 months
Trial Locations
- Locations (1)
Institute Dante Pazzanese of Cardiology
🇧🇷Sao Paolo, Brazil