NCT03175744暂停不适用
Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries
Spectranetics Corporation30 个研究点 分布在 5 个国家目标入组 82 人开始时间: 2017年5月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 82
- 试验地点
- 30
- 主要终点
- Freedom from Major Adverse Limb Event (MALE)
研究概览
简要总结
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford Clinical Category 4-5
- •Life expectancy > 1 year
- •Significant stenosis ≥70%
- •Patent inflow artery
- •Target vessel(s) diameter between 2 and 4 mm
- •Target vessel(s) reconstitute(s) at the ankle
排除标准
- •Pregnant or planning to become pregnant
- •History of stroke within 3 months
- •Planned major amputation
- •eGFR <30
- •Acute limb ischemia
- •Prior stent placement in target lesion
结局指标
主要结局
Freedom from Major Adverse Limb Event (MALE)
时间窗: 30 days
Composite of major amputation or major reintervention on a per patient basis
Freedom from Perioperative Death (POD)
时间窗: 30 days
Death on a per patient basis
Patency
时间窗: 6 months
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Limb Salvage
时间窗: 6 months
Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
次要结局
- Clinically-driven target lesion revascularization(6 months)
- Major adverse event rates(6 months)
- Patency rate(6 months)
研究者
研究点 (30)
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