JPRN-UMIN000003291已完成3 期
Occlusive/Stenotic Peripheral artery REvascularization study - OSPREY
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Terminal illness in whom life expectancy is expected to be less than 3 years. (2) Patients who are participating in other clinical study of medical device or pharmaceuticals within 3months before registration. (3) Already participated in this study in the past. (4) Previously received a bypass surgery, stent implantation or any surgery at SFA or distally. (5) Scheduled for a staged procedure to treat lesions within the aorta or ipsilateral run-off vessels after enrollment. (6) Allergy or experienced an anaphylactic symptom to components of the study device. (7) Acute or chronic renal failure (serum creatinine 2.0mg/dL or more) (8) Advanced calcification or excessive tortuosity at target lesion (9) Patients who are pregnant or breast-feeding, or in whom these conditions are possible. (10) Patients who were judged to be inappropriate for participation in the study due to severe or uncontrolled systemic disease of any condition by the principal investigators/investigators.
研究者
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