NCT00595959已完成3 期
CLiRpath® Excimer Laser System to Enlarge Lumen Openings
Spectranetics Corporation0 个研究点目标入组 65 人开始时间: 2006年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- Laser Success
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and popliteal arteries above the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •General Inclusion Criteria
- •1. Peripheral vascular disease Rutherford Classification 1, 2, or 3;
- •2. Eligible for revascularization of native vessel (PTA or bypass);
- •3. Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations;
- •4. Written informed consent given before execution of study procedures; and
- •5. Age \> 18 and ≤ 85 years.
- •Angiographic Inclusion Criteria
- •1. Reference vessel diameter \>/= 4.0 mm and ≤ 7.0 mm as determined by physician visual angiographic assessment of the most normally appearing vessel segment within 10 mm proximal AND 10 mm distal to the target segment.
- •2. Stenosis within the SFA and/or popliteal artery above the knee of \>/= 70% and \/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographic assessment at the time of the procedure, separate multiple lesions can be combined as two separate treatment areas as long as the sum total of all lesion lengths and/or treatment areas does not exceed 1.0 cm to 15.0 cm.
- •5. Patency (\< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery.
排除标准
- •General Exclusion Criteria
- •Contraindication to intravenous contrast material, heparin, aspirin or other medications required for a percutaneous interventional procedure;
- •Known bleeding or hyper-coagulation disorder;
- •Serum creatinine > 2.0 mg/dL;
- •Uncompensated congestive heart failure;
- •Current enrollment in any investigational study wherein patient participation has not been completed;
- •Prior enrollment in this study;
- •Suspected or confirmed pregnancy;
- •Any patient, who in the opinion of the investigator, would not be a good candidate for enrollment;
- •Myocardial infarction within 60 days; and
- •CVA/TIA within 60 days. Angiographic Exclusion Criteria
- •Subintimal guidewire placement following pilot channel creation through a stenosis or occlusion with any excimer laser catheter, as visualized with IVUS;
- •Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath® Photoablation Atherectomy system;
- •Ipsilateral and/or contralateral iliac stenosis >/= 50% DS that is not treated prior to enrollment in this study;
- •Ipsilateral and/or contralateral iliac treatment of a stenosis prior to enrollment with final residual stenosis >/= 30%, as determined in at least two (2) orthogonal views and documented by angiography;
- •Iliac treatment prior to enrollment where a perforation occurred requiring a covered stent, blood transfusion, or surgery for treatment of the perforation;
- •Identification of any lesion above the knee and/or below the knee in the treated leg (ipsilateral) that will require preplanned or predicted treatment within six (6) months after enrollment and prior to the completion of the six (6) month follow-up, including the iliac artery, the common femoral artery, the peroneal, anterior tibial, or posterior tibial arteries, or any area from the iliacs to the foot outside of the treatment area;
- •Lesions proximal and distal to the treatment site that are >/= 50% DS at time of enrollment;
- •Contralateral leg disease that requires treatment within the next 30 days and prior to completion of the 30 day follow-up;
- •Cardiovascular surgical or cardiovascular interventional procedures (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to enrollment in this study;
- •Planned or predicted cardiovascular surgical or interventional procedures outside of the ipsilateral leg (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoro-popliteal, and contralateral below the knee) within 30 days after entry into this study, and prior to completion of the 30-day follow-up; and
- •Perforation or dissection of grade "C" or greater seen during or after the creation of the pilot channel.
结局指标
主要结局
Laser Success
时间窗: Measured at time of procedure
The primary efficacy endpoint is laser success, defined as achieving \>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.
Major Adverse Events
时间窗: From discharge through the 6 month follow-up
The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.
次要结局
- Procedural Success(measured at time of procedure)
- Minimum and Maximum Lumen Diameters(measured at time of procedure)
- Clinical Success(measured post discharge thorugh 12 Months follow-up)
- Assisted Primary Patency(Through 12 Months)
- Assisted Secondary Patency(Through 12 Month)
- Patients With >50% Stenosis Measured by Duplex Ultrasound(Through 12 Month)
- Rutherford Classification(Through 12 Months)
- Adverse Events(Through 12 Months)
- Volumetric Plaque Reduction(measured at time of procedure)
研究者
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