ACTRN12622000071729尚未招募未知
A Prospective, Multicenter, Single Arm, Non-Randomized, Study to Assess the Performance and Safety of BD (TM) Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries
Becton, Dickinson and Company (BD)0 个研究点目标入组 50 人开始时间: 2022年1月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Greater than or equal to 18 years of age
- •Rutherford Clinical Category 2-4
- •Lesion greater than or equal to 70% stenosis by visual estimate
- •Lesion Length greater than or equal to 3 cm and less than or equal to 17 cm
- •Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix
排除标准
- •Less than or equal to 90 years of age
- •Life expectancy of less than 2 years
- •Participant has acute limb ischemia
- •Severe Calcification as defined as PARC scoring system
- •Participant is currently participating in an investigational drug or device study, or previously enrolled in a trial within the last 30 days prior to screening.
研究者
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