NCT03606629已完成不适用
Solaris Endoprosthesis Performance in Treatment of Patients With Peripheral Occlusive Arterial Disease in the Iliac Territory - Post-Marketing Solaris I Study.
Scitech Produtos Medicos Ltda1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Major Adverse Events
研究概览
简要总结
Fifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Rutherford Class 2 to 5;
- •Tasc II Class A, B, C or D;
- •Unilateral or bilateral lesion, de novo or restenotic but not in-stent;
- •Target lesion of 3 to 10 cm length;
- •≥ 50% stenosis or common iliac or external iliac artery;
- •Reference vessel diameter ≥ 5 and ≤ 9 mm;
- •Deep femoral artery patent and at least one infrapopliteal artery patent;
- •Informed Consent provided.
排除标准
- •Thrombocytopenia induced by heparina or tPA intravenous, clopidogrel, ticlopidine or aspirin sensitivity;
- •Target lesion near to aneurysm, highly calcified or excessively tortuous;
- •Previous stent on target vessel;
- •Presence of other lesions that need treatment within 30 days;
- •Rutherford Class 6;
- •Acute thrombotic occlusion;
- •History on amputation on the target limb.
结局指标
主要结局
Major Adverse Events
时间窗: 1 day
MAE is defined as death related to study device/ procedure, Myocardial Infarction, Target Vessel Revascularization or member amputation
Target Lesion Patency
时间窗: 6 months
Stenosis \< 50% and systolic velocity up to 2.5 cm2/s and no TLR
次要结局
未报告次要终点
研究者
研究点 (1)
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