BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 186
- 试验地点
- 11
- 主要终点
- Freedom from in-stent restenosis at 1 year
研究概览
简要总结
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1 Enlargement of endovascular therapy indication was based on patient choice for a less invasive technique and evidence based medicine. Consequently, TASC classification of lesions has been modified to reflect increased evidence for endovascular treatment of more extensive femoropopliteal lesions, and indication for endovascular repair has been enlarged to more severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the interventionalists have at their disposal a huge tool box. Evaluation of these tools is crucial to determine the right treatment strategy to avoid further reinterventions and overcosts.
The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee intermediate length femoropopliteal lesions.
From hospitals in Europe (France, Switzerland) we will randomly assign patients with symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patient ≥18 years
- •Patient has a history of symptomatic peripheral arterial disease (Rutherford classification: 2-5)
- •Lesion is eligible for treatment with a maximum of 2 stents per lesion (treatment of both legs is not permitted)
- •Patient is affiliated to the Social Security or equivalent system
- •Patient has been informed of the nature of the study, agrees to its provisions (and only for swiss centers, has signed the informed consent form prior to any study related procedure)
- •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
- •Reference vessel diameter 4 to 7-mm determined by CT scan (RVD obtained from averaging 5-mm segments proximal and distal to the lesions)
- •Target lesion has a pre-procedure percent diameter stenosis of ≥ 50% DS
- •De novo atherosclerotic lesions (stenosis and/or occlusion) of the superficial femoral artery, the proximal popliteal artery (P1), or both. The treatment area in the SFA and popliteal artery extended from 1 cm below the origin of the profunda femoris artery to 3 cm above the proximal margin of the intercondylar fossa of the femur.
- •Target lesion (single or multiple) has a maximal total length =14-cm and a minimal length = 2-cm
- •At least 1 patent runoff vessel (<50% DS throughout its course). The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon.
排除标准
- •Asymptomatic lesion
- •Restenosis
- •No atheromatous disease
- •Untreated >50% DS of the inflow tract
- •Resting ankle brachial index (ABI) unavailable
- •Female of child bearing potential
- •Patient has received, or is on the waiting list for a major organ transplant
- •Patient has a history of coagulopathy or will refuse blood transfusions
- •Patient is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
- •Severe concomitant disease with life expectation < one year
- •Known allergy to paclitaxel
- •Contraindication to Aspirin or Clopidogrel and Ticlopidin (the patient must be able to receive Dual Anti-Platelet Treatment for 2 months after the procedure)
- •Patient has an infected wound or osteomyelitis on the ipsilateral extremity or foot.
- •Patient has had prior major amputation to the ipsilateral (target) extremity
- •Patient is not able to give informed consent (and only for swiss centers)
- •Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials
- •Patient has previously had, or requires, bypass surgery, endarterectomy or other vascular surgery on any vessel of the ipsilateral extremity
- •In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Target lesion lies within or adjacent to an aneurysm
- •Patient with an allergy to contrast agent
- •Patient with a severe allergy to metal
- •Surgery or endovascular intervention of the target member within 14 days preceding the BATTLE procedure
研究组 & 干预措施
Misago RX (Misago RX, Terumo Corp., Tokyo
The Misago RX is a peripheral stent (Misago RX, Terumo Corp., Tokyo, Japan) indicated to treat iliac and femoropopliteal arteries. The Misago RX is a flexible self-expanding nitinol stent that is delivered via a RX monorail delivery catheter.
干预措施: Misago RX (Device)
Zilver PTX (Cook Medical, Bloomington, IN, USA)
Zilver PTX (Cook Medical, Bloomington, IN, USA) is a nitinol stent with a polymer-free paclitaxel coating designed to treat the above- the-knee femoropopliteal arteries. The anti-proliferative drug is the paclitaxel, a cytotoxic drug. The Zilver PTX stent is delivered via a over-the-wire system.
干预措施: Zilver PTX (Device)
结局指标
主要结局
Freedom from in-stent restenosis at 1 year
时间窗: 1 year
It was defined by restenosis of \>50% and by a peak systolic velocity index \>2.4 at the target lesion.
次要结局
- Primary sustained clinical improvement(1 month, 12 months and 24 months)
- Target lesion revascularization (TLR)(1 month, 12 months and 24 months)
- residual diameter stenosis(Day 0)
- Secondary sustained clinical improvement(1 month, 12 months and 24 months)
- Primary patency(1 month, 12 months and 24 months)
- Major adverse events(1 month, 12 months and 24 months)
- Limb salvage(1 month, 12 months and 24 months)
- Death(1 month, 12 months and 24 months)
- Ankle brachial index(1 month, 6 months, 12 months and 24 months)
- Target Extremity Revascularization (TER)(1 month, 12 months and 24 months)
- Stent fracture(1 month, 12 months and 24 months)
- EQ-5D-3L questionnaire(1 month, 12 months and 24 months)
- Economic analysis objective(2 years)