NCT01366482已完成不适用
Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
Medtronic Endovascular1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Target Lesion Percent Stenosis
研究概览
简要总结
The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford Clinical Category 2-4
- •At least 18 years of age
- •Is able and willing to provide written informed consent prior to study specific procedures
排除标准
- •Has a life expectancy of less than 24 months
- •Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
- •Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs
结局指标
主要结局
Target Lesion Percent Stenosis
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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