NCT01305070已完成4 期
Femoral Artery In-Stent Restenosis (FAIR) Trial
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2010年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA)
研究概览
简要总结
Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years old.
- •Patient must sign informed consent form.
- •Patient must agree to participate in the study and comply with follow-up requirements.
- •Clinically, all patients must be in Rutherford category 2 to
- •Angiographic Inclusion Criteria:
- •Planned angioplasty of in-stent restenoses (degree of stenosis 70-100%) within the SFA. The target lesion must not extend beyond the stent margins. In cases of two or more stenotic regions within the stented segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered a single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion!
- •The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
- •The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound.
- •The target lesion region starts at the origin of the SFA and ends distally at the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection).
- •Patency (< 50% stenosis) of popliteal artery and at least 1 infragenicular artery.
排除标准
- •Patient is currently participating in another clinical trial.
- •Pregnancy or pregnancy planned during study duration.
- •Life expectancy less than 1 year.
- •Co-morbidities preventing study participation.
- •Severe coagulation disorders.
- •Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
- •Active gastric ulcer or gastrointestinal bleeding.
- •Thrombotic occlusion of the target vessel within previous 4 weeks.
- •Treatment of target lesion with laser or atherectomy devices.
- •Dialysis dependency.
- •Manifest hyperthyreosis.
- •Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
- •Known heparin intolerance.
- •Known paclitaxel intolerance.
- •Angiographic:
- •Target lesion extends into the popliteal artery.
- •Symptomatic untreated inflow lesion > 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible.
- •SFA lesions > 50% stenosis proximal and/or distal to the target lesion that require treatment.
- •Target lesion extends beyond the stent margins.
研究组 & 干预措施
Standart balloon angioplasty
Active Comparator
Admiral Xtreme, Invatec
干预措施: Admiral Xtreme (Device)
Paclitaxel-eluting balloon arm
Active Comparator
In.Pact Admiral, Invatec
干预措施: In.Pact Admiral (Device)
结局指标
主要结局
Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA)
时间窗: 6 month
Binary restenosis rate by Duplex-ultrasound \>= 50% measured as proximal peak velocity ratio PVR\[prox\] \>= 2.4
次要结局
- Death(12 month)
- Recurrent stenosis >= 70% within the stent at 6 and 12 month(6 and 12 month)
- Primary angiographic success rate(12 month)
- Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points(6 and 12 month)
- Recurrent restenosis within the stent at 12 month(12 month)
- Clinical and hemodynamic parameters(at 1, 6 and 12 month)
- Major adverse vascular events (MAVE)(12 month)
- Clinically driven target lesion revascularization (TLR) at 6 and 12 month(6 and 12 month)
研究者
研究点 (1)
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