jRCT2052190025进行中(未招募)不适用
Multi-center, open-label, single-arm study on the endovascular visualization capability of an OFDI (Optical Frequency Domain Imaging) catheter for obstructive arteriosclerosis of lower extremities
未提供0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit(—)
- 性别
- All
入选标准
- •(1) Patients who undergo endovascular treatment based on guidelines for the management of PAD (peripheral arterial diseases) (JCS 2015) (2) Patients whose target lesion site exists from the superficial femoral artery to the peripheral side (3) Patients who are at least 20 years at the time of consent acquisition
排除标准
- •(1) Patients who have a history of bypass surgery (2) Patients with endovascular treatment (stent placement excluding balloon treatment) for PAD of lower extremities in the past and re-treat the same lesion (3) Patients who have serious allergies to contrast (4) Patients who have renal dysfunction with eGFR (MDRD calculation formula) less than 30 mL / min / 1.73 m2 (5) Patients with platelet count less than 100000 / microL (6) Patients contraindicated for antiplatelet or anticoagulant therapy (7)Patients decided not applicable for this study by physician
结局指标
主要结局
-
Technical success (observation of the blood vessel lumen over 3/4 round)
次要结局
未报告次要终点
研究者
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