NCT00930813已完成1 期
A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting.
C. R. Bard10 个研究点 分布在 2 个国家目标入组 101 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Angiographic Late Lumen Loss
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
详细描述
The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.
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
- Single (Participant)
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
- •Clinical Criteria
- •Male or non-pregnant female ≥18 years of age.
- •Rutherford Clinical Category 2-5
- •Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria
- •A single de novo or restenotic atherosclerotic lesion >70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length.
- •Reference vessel diameter ≥4 mm and ≤ 6mm
- •Successful wire crossing of lesion
- •A patent inflow artery free from significant lesion (>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)
排除标准
- •Pregnant or planning on becoming pregnant in < 2yrs
- •Live expectancy of <2 years
- •Patient actively participating in another investigational device or drug study
- •History of hemorrhagic stroke within 3 months
- •Previous or planned surgical or interventional procedure within 30 days of index procedure
- •Chronic renal insufficiency with creatinine >2.5 mg/L
- •Prior surgery of the target lesion
- •Inability to take required study medications
- •Anticipated use of IIb/IIIa inhibitor prior to randomization
- •Lesion length is <4 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
- •Known inadequate distal outflow
- •Significant inflow disease
- •Acute or sub-acute thrombus in target vessel
- •Severe lesion calcification
- •Acute vessel occlusion or sudden symptom onset
- •Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
- •Prior participation in the current study
研究组 & 干预措施
Lutonix Catheter
Experimental
Paclitaxel coated Balloon Catheter
干预措施: Lutonix Catheter (Device)
Standard uncoated Balloon Angioplasty Catheter
Active Comparator
uncoated angioplasty balloon
干预措施: Standard uncoated Balloon Angioplasty Catheter (Device)
结局指标
主要结局
Angiographic Late Lumen Loss
时间窗: 6 months
Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.
次要结局
- Safety - Device Related Adverse Events(30 days)
- Target Vessel Revascularization(6, 12, 24 months)
- Target Lesion Revascularization(6, 12, 24 months)
- Primary Patency of Treated Segment(6, 12, 24 months)
- Serum Paclitaxel Levels - in Subsets of Patients(0, 1, 3 hours and pre-discharge)
- Device Success(at procedure)
- Procedural Success(at procedure)
- Change in Ankle-brachial Index(pre-procedure, 6, 12 and 24 months)
- Change in Rutherford Grade(pre-procedure,6, 12 and 24 months)
- Change in Walking Impairment Questionnaire (WIQ)(pre-procedure, 6, 12 and 24 months)
研究者
研究点 (10)
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