NCT00233714已完成1 期
A Randomized Feasibility Study of the Double Dose or Single Dose Sirolimus-Eluting BX VELOCITY Balloon-Expandable Stent for the Treatment of Diabetic Patients With de Novo Native Coronary Artery Lesions(3D)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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);
研究组 & 干预措施
1
Active Comparator
Single-dose Sirolimus-Eluting Coronary stent
干预措施: CYPHER Sirolimus-Eluting Coronary Stent (Device)
2
Active Comparator
Double-dose Sirolimus-Eluting Coronary stent
干预措施: CYPHER Sirolimus-Eluting Coronary Stent (Device)
结局指标
主要结局
The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.
时间窗: 6 months post-procedure
次要结局
- 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)
研究者
研究点 (1)
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