JPRN-UMIN000042695已完成3 期
A Comparative Clinical Trial for Critical Limb Ischemia with Paclitaxel Coating Balloon Catheter (JLL-LEG). - The JLL-LEG Pivotal Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
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) Subject who undergoes EVT as a pretreatment for major amputation or who is expected to cannot avoid major amputation even if EVT is performed. (2) Subject with severe heart failure. (3) Subject with untreated severe coronary artery disease. (4) Subject with severe infection. (5) Subject with ulcers on the heel. (6) Subject with inflammation extending to the sole of the foot. (7) Subject with accumulated pus in the wounds. (8) Subject with taking steroids. (9) Subject with albumin value less than 2.5 g/dl. (10) Subject with low ADL (WHO PS score of 4 or more). Except when it is caused by the underlying disease. (11) Subject with ulcers that are unlikely to becaused by lower limb ischemia, because lower limb blood flow is evaluated to be sufficiently by objective blood flow assessment (angiography, echo, etc.). (12) Subject with ulcers caused by primary diseases other than arteriosclerosis such as vasculitis. (13) Subject with major amputation on the contralateral limb. (14) Subject with Rutherford categories 6 on the contralateral limb. (15) Subject with pregnant or possibly pregnant and lactating. (16) Subject with hypersensitivity reaction to aspirin, heparin, clopidogrel or ticlopidine. (17) Subject with a history of contraindications or allergies to contrast agents. However, subject with a history of allergies are excluded when preoperative administration of steroids can prevent symptoms. (18) Subject with bleeding tendency or abnormal blood coagulation, who cannot perform emergency blood transfusion, or who is contraindicated for antiplatelet drugs. (19) Subject with stroke or transient ischemic attack (TIA) within 6 months before preoperative. (20) Subject with treatment history of abdominal aorta within 1 month before preoperative. (21) Subject who have paclitaxel-eluting stents placed on the target limbs within 1 year before preoperative.
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