An Evaluation of the Sirolimus Coated Modified BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo or Restenotic Native Coronary Artery Lesions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
研究概览
简要总结
This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.
详细描述
This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions <=18mm in length and >=3.0 to >=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
- •Single de novo or restenotic lesion requiring treatment in a major native coronary artery;
- •Target lesion is <=18mm in length (visual estimate);
- •Target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
- •Target lesion stenosis is >50% and <100% (visual estimate);
排除标准
- •A 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;
- •Have an ostial target lesion;
- •Angiographic evidence of thrombus within target lesion;
- •Calcified lesions which cannot be successfully predilated;
- •Ejection fraction <=30%;
- •Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
- •Totally occluded vessel;
研究组 & 干预措施
2
sirolimus coated Bx VELOCITY stent - slow release
干预措施: sirolimus coated Bx VELOCITY stent - slow release (Device)
1
sirolimus coated Bx VELOCITY stent - fast release
干预措施: sirolimus coated Bx VELOCITY stent - fast release (Device)
结局指标
主要结局
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
时间窗: post procedure and 6 months
次要结局
- Target vessel failure (TVF).(6 months)
- Assessment of lesion morphology by intravascular ultrasound (IVUS).(post procedure and 6 months)