NCT01790243已完成不适用
A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)
C. R. Bard15 个研究点 分布在 1 个国家目标入组 1,189 人开始时间: 2011年7月20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
- 1,189
- 试验地点
- 15
- 主要终点
- Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
研究概览
简要总结
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
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
- 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 Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure.
时间窗: From index procedure to 60 months Post Index Procedure
次要结局
- Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline(6, 12, and 24 months post index procedure)
- Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure(30 days post index procedure)
- Number of Participants With Technical and Procedural Success(At time of index procedure)
- Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Participants With All-Cause Perioperative (<30 Day) Death, 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 (PPI))
- Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure(6, 12, and 24 months post index procedure)
- Number of Acute Device Success at Time of Index Procedure(At time of index procedure)
- Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline(6, 12, and 24 months from baseline)
研究者
研究点 (15)
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