NCT02278991已完成不适用
A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries
C. R. Bard12 个研究点 分布在 3 个国家目标入组 149 人开始时间: 2014年10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
- 149
- 试验地点
- 12
- 主要终点
- Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
研究概览
简要总结
Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.
详细描述
The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery [SFA] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).
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
- •Subjects will be included if all of the following inclusion criteria apply:
- •Age ≥18 years;
- •The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
- •Rutherford Category 2-4;
- •Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of ≥50% stenosis or occlusion (by visual estimate) and is amenable to treatment with LifeStent® and Lutonix DCB;
- •Patients must be able to be treated with Lutonix DCB and LifeStent®;
- •Total Lutonix DCB treated segment(s) of 10-24 cm in length;
- •Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
- •At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with LifeStent®).
- •No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
- •Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to index procedure;
- •Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the tibioperoneal trunk.
排除标准
- •Pregnant, lactating, or planning on becoming pregnant or men intending to father children;
- •Contraindication to Lutonix DCB or LifeStent® per current IFU;
- •Life expectancy of <1 year;
- •Inability to take required antiplatelet/anticoagulant medications per the LifeStent® and Lutonix DCB IFU, or known contraindication (including allergic reaction) or sensitivity to contrast media, nickel, titanium or tantalum that cannot be adequately managed with pre- and post-procedure medication;
- •Intended treatment of outflow disease during the index procedure;
- •Intended use of laser, atherectomy or cryoplasty during index procedure;
- •Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target vessel;
- •History of stroke within 3 months;
- •History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
- •Participation in an investigational drug or another investigational device study until this study's (Lutonix LifeStent® Study) primary endpoint is reached or previous enrollment in this study;
- •Another medical condition, which, in the opinion of the Investigator, may cause the patient to be noncompliant with the CIP or confound data interpretation;
- •Target vessel and/or lesion involves a previously placed stent.
结局指标
主要结局
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
时间窗: 30 days
Freedom from the composite endpoint of death, index limb amputation, and target vessel revascularization at 30 days.
Primary patency at 12 months.
时间窗: 12 months
Primary patency is defined as the absence of target lesion restenosis and freedom from target lesion revascularization.
次要结局
- All-cause death(30 days, 6, 12 and 24 months)
- Amputation (above the ankle)-free survival(30 days, 6, 12 and 24 months)
- Freedom from Target Lesion Revascularization after 30 days, and 6, 12 and 24 months post-index procedure.(30 days, 6, 12 and 24 months)
- Change in resting ankle brachial index (ABI) from baseline to 30 days, and 6, 12 and 24 months post-index procedure(30 days, 6, 12 and 24 months)
- Procedural success(Immediately after Intervention)
- Device success(Immediately after intervention)
- Technical success(Immediately after intervention)
- Freedom from TVR after 30 days, and 6, 12 and 24 months post-index procedure.(30 days, 6, 12 and 24 months)
- Change in Rutherford Classification from baseline to 30 days, and 6, 12 and 24 months post-index procedure(30 days, 6, 12 and 24 months)
- Target limb reintervention for treatment of thrombosis of target vessel or embolization to its distal vasculature(30 days, 6, 12 and 24 months)
研究者
研究点 (12)
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