NCT01305174终止4 期
Balloon Expandable vs. Selfexpanding Stents to Treat Stenosis or Occlusions of Common and External Iliac Artery Disease
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.2 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Duplex-ultrasound determined recurrent restenosis after 12 month
研究概览
简要总结
The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease.
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.
- •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 1 to
- •Angiographic Inclusion Criteria:
- •Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries.
- •Lesion segment starts at the aortic bifurcation and ends at the take off of the common femoral artery (Offset of the iliac circumflex artery beneath the ligamentum inguinale).
- •The length of the 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 or (MR-) angiography.
- •Patency of ipsilateral profunda artery. Ipsi- or contralateral artery lesions of the leg can be treated prior to the treatment of the study lesion.
- •In cases of two or more stenotic regions within the 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 as single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion!
- •A tandem lesion that can be treated with one stent will be considered as one lesion.
排除标准
- •Patient is currently participating in another clinical trial
- •Pregnancy or pregnancy planned during study duration
- •Life expectancy less than 2 years
- •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 femoral artery.
- •Symptomatic untreated inflow lesion > 70% in ipsilateral iliac arteries. Pretreatment of iliac stenosis is possible.
- •Target Lesion is in aortic bifurcation and needs treatment with "kissing balloon technique"
- •Lesion in abdominal aorta that needs treatment.
结局指标
主要结局
Duplex-ultrasound determined recurrent restenosis after 12 month
时间窗: 12 month
Duplex-ultrasound definition: = recurrent stenosis ≥ 70% in relation to vessel diameter or PSV \>3.4 per duplex ultrasound
次要结局
- Major adverse vascular events plus death rate(24 month)
- Clinical improvement of walking distance and improvement of at least 1 Rutherford category(12 and 24 month)
- Recurrent stenosis >= 70%within the stent at 6 and 12 month(at 6 and 12 month)
- Clinical and hemodynamic parameters (walking distance, ABI, Rutherford category) at 1, 6 and 12 month(at 1, 6 and 12 month)
- Clinically driven target lesion revascularization (TLR and TVR) at 6 and 12 month(at 6 and 12 month)
- Primary angiographic success rate (<30% residual stenosis)(Procedure)
- Improvement of ABI of at least o.1 points in treated leg after 6 and 12 month (AHA Guidlines)(6 and 12 month)
研究者
研究点 (2)
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