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
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);
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)
Loading locations...
相似试验
终止
2 期
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis ComplexAngiofibroma of FaceTuberous SclerosisNCT03363763Aucta Pharmaceuticals, Inc24
已完成
1 期
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)Obstructive Sleep Apnea (OSA)NCT03882801Merck Sharp & Dohme LLC24
已完成
3 期
Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)Coronary Artery DiseaseNCT00232765Cordis Corporation1,058
撤回
1 期
Sirolimus for Improving Social Abilities in People With PTEN Germline MutationsPTEN Gene MutationPTEN Hamartoma Tumor SyndromePTEN Hamartoma SyndromeNCT06080165Stanford University
已完成
不适用
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side EffectsPregnancyNCT02159807St. Luke's-Roosevelt Hospital Center170