NCT02013271已完成不适用
A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries
C. R. Bard14 个研究点 分布在 5 个国家目标入组 125 人开始时间: 2013年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 14
- 主要终点
- Overall Medical Safety
研究概览
简要总结
To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
详细描述
The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm < RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).
The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years of age;
- •Rutherford Clinical Category 2-4;
- •The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
- •Angiographic Criteria
- •Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
- •TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
- •de novo lesion(s) or non-stented restenotic lesion(s) > 90 days from prior angioplasty procedure;
- •Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
- •Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;
- •Target vessel diameter between ≥ 4 and ≤ 7 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 (treatment of target lesion acceptable after successful treatment of iliac inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication.
- •Successful wire crossing and pre-dilatation of the target lesion; NOTE: Use of crossing devices allowed if necessary NOTE: Bare nitinol stenting of short segments (length minimized to the mechanical defect) is required after pre-dilatation to resolve flow-limiting dissections or if deemed clinically necessary.
- •At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
- •No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment.
排除标准
- •Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- •Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
- •Life expectancy of < 1year;
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
- •History of stroke within 3 months;
- •History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- •Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
- •Target lesion involves a previously placed stent
- •Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
- •No normal proximal artery segment in which duplex flow velocity can be measured;
- •Significant inflow disease. Successful treatment of inflow iliac disease allowed prior to target lesion treatment;
- •Unsuccessful crossing; NOTE: crossing devices allowed
- •Known inadequate distal outflow (> 50% stenosis of distal popliteal or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
- •Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel;
- •Intended use of laser, atherectomy or cryoplasty during the index procedure.
结局指标
主要结局
Overall Medical Safety
时间窗: 12 Months
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention. Success is freedom from all specified events; failure is one or more specified events occurs.
Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images
时间窗: 12 Months
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the independent, blinded core laboratory based on threshold Doppler PSVR ≥ 2.5 (together with wafeform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol). Clinically-Driven TLR is adjudicated by the Clincal Events Committee.
次要结局
- Secondary Endpoint Efficacy: Acute Device Success(During index procedure)
- Secondary Endpoint Efficacy: Technical Success(During index procedure)
- Secondary Endpoint Efficacy: Procedural Success(Until index hospitalization discharge)
- Secondary Endpoint Efficacy: Primary Patency(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Secondary Patency(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Clinically-driven Target Lesion Revascularization (TLR)(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Target Lesion Revascularization (TLR)(6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Efficacy: Change of Rutherford classification from baseline(6, 12, 24 months after index procedure)
- Secondary Endpoint Efficacy: Change of resting Ankle Brachial Index (ABI) from baseline(6, 12, 24 months after index procedure)
- Secondary Endpoint Efficacy: Change in Walking Impairment Questionnaire from baseline(6, 12, 24 months after index procedure)
- Secondary Endpoint Efficacy: Change in quality of life from baseline, as measured by EQ-5D(6, 12, 24 months after index procedure)
- Secondary Endpoint Medical Safety: Major vascular complications(≤30 days after index procedure)
- Secondary Endpoint Medical Safety: Composite Safety(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: All-cause death(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Major amputation at target limb(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Minor amputation at target limb(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Target Vessel Revascularization (TVR)(1, 6, 12, 24, 36 months after index procedure)
- Secondary Endpoint Medical Safety: Target Limb Reintervention(1, 6, 12, 24, 36 months after index procedure)
研究者
研究点 (14)
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