NCT01330628已完成2 期
EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Spectranetics Corporation68 个研究点 分布在 2 个国家目标入组 252 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 68
- 主要终点
- Freedom From Target Lesion Revascularization (TLR)
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAD with Rutherford class 1-4
- •Resting ABI <0.9 or abnormal exercise ABI <0.9
- •History of previous femoropopliteal nitinol stenting
- •Angiographic significant restenosis (>=50%)
- •Target lesion length >=4 cm; no more than 3 cm outside stent at either end
- •Vessel diameter >=5 mm and <=7 mm
- •At least one widely patent tibial or peroneal artery to the foot
排除标准
- •Patient is pregnant or breast feeding
- •Evidence of acute limb ischemia
- •Life expectancy <12 months
- •CVA within 60 days of screening
- •Myocardial infarction within 60 days of procedure
- •Known allergy to contract media
- •Known contraindication to aspirin, antiplatelet and anti-coagulation therapies
- •Uncontrolled hypercoagulability
- •Present or suspected systemic infection in target limb
- •Serum creatinine >= 2.5 mg/dl unless dialysis dependent
- •Previous treatment to target vessel within 3 months of study procedure
- •Drug eluting stents or covered stents in target lesion
- •Ipsilateral and/or contralateral iliac stenosis >= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis <= 30% documented by angiography
- •Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up
- •Identification of any lesion below the target stent in the treated leg >50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)
- •Tibial artery containing a >50% Diameter Stenosis (DS) by visual estimate after popliteal
- •Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
结局指标
主要结局
Freedom From Target Lesion Revascularization (TLR)
时间窗: 6 months
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Freedom From Major Adverse Events (MAE)
时间窗: 30 days
Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).
次要结局
未报告次要终点
研究者
研究点 (68)
Loading locations...
相似试验
已完成
不适用
Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb IschemiaCritical Limb IschemiaNCT01579123Baylor Research Institute200
已完成
不适用
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular DiseasePeripheral Arterial DiseaseNCT02653456Ra Medical Systems64
已完成
不适用
Safety and Effectiveness Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of HyperopiaHyperopiaNCT00762281Carl Zeiss Meditec, Inc.189
已完成
4 期
Presbyopic Supracor Treatment for Near Myopic/Hyperopic Pseudophakic EyesMyopiaPresbyopiaHyperopiaNCT01387360Technolas Perfect Vision GmbH33
已完成
不适用
Atherectomy By Laser Ablation With Turbo-ElitePeripheral Arterial DiseasePeripheral Vascular DiseaseNCT02307370Spectranetics Corporation44