NCT02063672已完成不适用
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
C. R. Bard40 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2014年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 40
- 主要终点
- Percentage of Participants Without Primary Safety Events
研究概览
简要总结
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).
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 (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
- •Male or non-pregnant female ≥18 years of age
- •Rutherford Clinical Category 2-4
- •Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
- •Lesion measures between 4 and 18 cm
- •Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
- •A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
- •Successful crossing and predilatation of the target lesion with a guidewire
- •At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized
- •No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment
排除标准
- •Life expectancy of <1 year
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study NOTE: Enrollment in another drug or device clinical trial during the follow up period is not allowed
- •History of stroke within 3 months
- •History of MI, thrombolysis or angina within 2 weeks of enrollment
- •Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion
- •Target lesion involves a previously placed covered stent or drug-eluting stent
- •Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent
- •Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
- •Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion
- •Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)
研究组 & 干预措施
Lutonix DCB
Experimental
Lutonix Paclitaxel Drug Coated Balloon
干预措施: Lutonix DCB (Device)
PTA Catheter
Active Comparator
Standard Uncoated Balloon Angioplasty Catheter
干预措施: Standard Uncoated Balloon Angioplasty Catheter (Device)
结局指标
主要结局
Percentage of Participants Without Primary Safety Events
时间窗: 12 Months
Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year
Percentage of Participants With Primary Patency at 1 Year
时间窗: 12 Months
Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.
次要结局
- Percentage of Participants Without Target Lesion Revascularization (TLR)(6 months and 12 months)
- Percentage of Participants With Device Success(During the Index Procedure (90 mins))
- Percentage of Participants With Primary Patency at 6 and 12 Months(6 months and 12 months)
- Change in Walking Impairment Questionnaire From Baseline(6 months and 12 months)
- Percentage of Participants With Technical Success(During the Index Procedure (90 mins))
- Percentage of Participants With Procedural Success(During the Index Procedure (90 mins))
- Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)(6 months and 12 months)
- Percentage of Participants With Sustained Clinical Benefit Compared to Baseline(6 months and 12 months)
- Percentage of Participants Without Major Vascular Complications (≤30 Day)(30 Days)
- Percentage of Participants Without All-Cause Death(1 month, 6 months, and 12 months)
- Percentage of Participants Without Major Limb Amputation(1 month, 6 months, and 12 months)
- Percentage of Participants With Secondary Patency at 6 Months and 12 Months(6 months and 12 months)
- Change of Rutherford Classification From Baseline(6 months and 12 months)
- Change of Resting Ankle Brachial Index (ABI) From Baseline(6 months and 12 months)
- Change in Quality of Life From Baseline(6 months and 12 Months)
- Percentage of Participants Without Minor Limb Amputation(1 month, 6 months, and 12 months)
- Percentage of Participants Without Target Vessel Revascularizations (TVR)(1 month, 6 months, and 12 months)
- Percentage of Participants Without Any Target Limb Reinterventions(1 month, 6 months, and 12 months)
研究者
研究点 (40)
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