NCT01214148已完成1 期
A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- In-stent Late Lumen Loss
研究概览
简要总结
A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2 centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical follow-ups take place at 1 month and yearly up to three (3) years.
The objective of this trial is to assess the safety and clinical performance of the ORSIRO drug eluting stent in patients with single de-novo coronary artery lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 years old;
- •Clinical evidence of ischemic heart disease and / or a positive functional study. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4 ), or documented silent ischemia;
- •Single de novo lesion with ≥50% and <90% stenosis in 1 coronary artery;
排除标准
- •Documented left ventricular ejection fraction (LVEF) ≤30%;
- •Unstable angina pectoris(Braunwald Class A I-III)
- •Three-vessel coronary artery disease
- •Evidence of myocardial infarction within 72 hours prior to the index procedure;
- •Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately premedicated), cobalt-chromium (CoCr), Poly-L-Lactidic Acid (PLLA), silicon carbide (aSiC:H)
- •A platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3;
- •Acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or >150µmol/L);
- •Total occlusion (TIMI 0 or 1);
- •Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
- •Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
- •Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
- •Target lesion is located in or supplied by an arterial or venous bypass graft;
- •Ostial target lesion (within 5.0mm of vessel origin);
- •Target lesion involves a side branch >2.0mm in diameter;
- •Unprotected Left main coronary artery disease (stenosis >50%);
结局指标
主要结局
In-stent Late Lumen Loss
时间窗: 9 months post procedure
次要结局
- In-stent and in-segment (proximal and distal) minimum lumen diameter(4 and 9 months post-procedure)
- In-stent and in-segment binary restenosis rate(4 and 9 months post procedure.)
- In-segment late lumen loss(4 and 9 months post procedure)
- In-stent late lumen loss(4 months post procedure.)
- Target Lesion Revascularization(1, 4 and 9 months and at 1, 2 and 3 years post-procedure)
- Clinically driven target lesion revascularization(1, 4 and 9 months and at 1, 2 and 3 years post-procedure)
- Target Vessel Revascularization(1, 4 and 9 months and at 1, 2 and 3 years post-procedure)
- - Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization(1, 4 and 9 month post-procedure, and yearly up to 3 years)
- - Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels(3 years post procedure)
- Stent thrombosis(1, 4 and 9 months and 1, 2 and 3 years post-procedure)
- Neointimal hyperplasia volume (subgroup)(4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS))
研究者
研究点 (2)
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