ACTRN12613000336785进行中（未招募）未知
ProspectIve, SingLe-Arm, MuLti-Center, Pharmacokinetic Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
Spectranetics0 个研究点目标入组 25 人开始时间: 2013年3月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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 o limit（—）
- 性别
- All
入选标准
- •Subjects can be enrolled if they have symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery; Rutherford classification of 2, 3 or 4; de novo or restenotic lesion(s) >70% within the SFA and/or popliteal artery that are greater than or equal to 3 cm and less than or equal to 20 cm in cumulative total length with a reference vessel diameter of greater than or equal to 4 mm and less than or equal to 6 mm and with at least one patent outflow vessel.
排除标准
- •Patients will be excluded if they have a known intolerance to study medications, paclitaxel or contrast agents, a drug coated or drug eluting stent or balloon implanted/used within 12 months of the interventional procedure, require the use of adjunctive therapies or have prohibitive calcification that precludes adequate treatment.
研究者
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