NCT01628159已完成不适用
A Prospective, Multicenter, LEVANT 2 Continuation Registry of the Moxy™ Drug Coated Balloon for Treatment of Femoropopliteal Arteries
C. R. Bard104 个研究点 分布在 4 个国家目标入组 657 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 657
- 试验地点
- 104
- 主要终点
- Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure
研究概览
简要总结
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.
详细描述
The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries through 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Inclusion Criteria:
- •Male or non-pregnant female ≥18 years of age;
- •Rutherford Clinical Category 2-4;
- •Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
- •Angiographic Lesion Inclusion Criteria:
- •Length ≤15 cm;
- •Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of <15 cm);
- •≥70% stenosis by visual estimate;
- •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 TP trunk;
- •de novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
- •Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
- •Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
- •Successful, uncomplicated (without use of a crossing device) antegrade 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); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
- •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);
- •Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
- •No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
排除标准
- •Patients will be excluded if ANY of the following conditions apply:
- •Pregnant or planning on becoming pregnant or men intending to father children;
- •Life expectancy of <5 years;
- •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
- •History of hemorrhagic stroke within 3 months;
- •Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
- •History of MI, thrombolysis or angina within 2 weeks of enrollment;
- •Rutherford Class 0, 1, 5 or 6;
- •Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
- •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;
- •Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
- •Anticipated use of IIb/IIIa inhibitor prior to randomization;
- •Ipsilateral retrograde access;
- •Composite lesion length is >15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
- •Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
- •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;
- •Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
- •Severe calcification that renders the lesion un-dilatable;
- •Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
结局指标
主要结局
Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure
时间窗: 60 months Post Index Procedure
次要结局
- Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Participants With Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure (PPI)(1, 6, 12, 24, 36, 48, and 60 months post index procedure)
- Number of Participants With Technical and Procedural Success(At time of index procedure)
- Number of Acute Device Success at Time of Index Procedure(At time of Index Procedure)
- Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure(1, 6, 12, and 24 months post index procedure)
- Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure(1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure)
- Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure(30 days post index procedure)
- Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
研究者
研究点 (104)
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