NCT00130546已完成3 期
A Prospective, Randomized Intra-Individual Study With the Sirolimus Coated Cypher Select(TM) and the Paclitaxel(TM) Coated Express Balloon Expandable Stents for the Treatment of Patients With Two de Novo Native Coronary Artery Lesions.
University Hospital Freiburg2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2004年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography
研究概览
简要总结
The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).
详细描述
This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers).
A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤ 30 mm in length and ≥ 2.25 mm to < 3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be >=18 and <=85 years of age
- •Female of childbearing potential must have a negative pregnancy test at the time of enrolment and utilize reliable birth control for the duration of their participation in the trial
- •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) and documented ischemia OR patients with documented silent ischemia
- •Two or more de novo lesions < 30 mm in length (visual estimate)
- •Target vessel at lesion site is ≥ 2.25 mm and ≤ 3.0 mm in diameter (visual estimate)
- •Target lesion is located in a native coronary artery which can be covered by one stent (single lesion)
- •Acceptable candidate for coronary artery bypass surgery (CABG)
- •Target lesion stenosis is > 50% and < 100% (thrombolysis in myocardial infarction [TIMI] 1) (visual estimate)
- •Target lesions do not differ in length for more than 6 mm
- •Patient is willing to comply with the specified follow-up evaluation
- •Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee
排除标准
- •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
- •Impaired runoff in the treatment vessel with diffuse distal disease
- •Ostial target lesion
- •Angiographic evidence of thrombus within target lesion
- •Calcified lesions which cannot be successfully predilated
- •Ejection fraction <= 30%
- •Totally occluded vessel (TIMI 0 level)
- •Impaired renal function (creatinine > 3.0 mg/dl)
- •Pretreatment with devices other than balloon angioplasty
- •Target lesion has excessive tortuosity unsuitable for stent delivery and deployment
- •Target lesion involves bifurcation including a side branch >= 2.5 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented
- •Prior stent within 5 mm of target lesion this includes in-stent restenosis
- •Significant (> 50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff
- •Intervention of another lesion has occurred within one month before or is planned or highly probable to be performed within the next 30 days after this index procedure
- •Recipient of heart transplant
- •Patient with a life expectancy less than 12 months
- •Known allergies to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), heparin stainless steel, contrast agent, Paclitaxel or Sirolimus
- •Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study
- •Target lesion located in an arterial or venous by-pass graft
- •Currently participating in an investigational drug or another device study
- •Unstable angina pectoris Braunwald Classification A I-II-III or is having a peri-infarction
结局指标
主要结局
The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography
时间窗: 8 months
次要结局
- Target lesion and vessel revascularization (TLR, TVR)(12 months)
- Major adverse cardiac events (MACE) at 30 days, 8 and 12 months(30 days, 8 and 12 months)
研究者
研究点 (2)
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