Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Angiographic restenosis at 6 months
研究概览
简要总结
Minimal invasive treatment (called "endovascular") of the arteries of the lower limb remains problematic, because recurrent disease ("restenosis") frequently leads to recurrent symptoms. As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial femoral artery (artery of the thigh). We investigated whether the use of a vascular endoprosthesis ("stent") improves patients´ outcome.
Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency after endovascular treatment of superficial femoral artery obstructions compared to balloon angioplasty with optional stenting.
详细描述
STUDY DESIGN. From June 2003 to August 2004, we screened consecutive patients referred for endovascular treatment of the SFA due to intermittent claudication or chronic critical limb ischemia for enrollment in a randomized single-institution trial. Patients who were potential candidates for percutaneous intervention were discussed twice weekly in a consensus meeting of angiologists, vascular surgeons and interventional radiologists prior to being considered for trial enrollment. The protocol was approved by the institutional ethics committee, and patients provided written informed consent.
The clinical criterion for study entry was symptomatic peripheral artery disease (PAD) with either severe intermittent claudication (Rutherford class 3) or chronic critical limb ischemia with rest pain (Rutherford class 4) or ischemic ulcers (Rutherford class 5)1. Anatomic inclusion criteria, based upon findings on biplane DSA at the time of intervention, were a >50% stenosis or occlusion of the ipsilateral SFA with a target lesion length above 30mm, and at least one patent (<50% stenosis) tibio-peroneal run-off vessel. Exclusion criteria were acute critical limb ischemia, previous bypass surgery or stenting of the SFA, untreated inflow disease of the ipsilateral pelvic arteries (>50% stenosis or occlusion), and known intolerance of study medications or contrast agent.
STUDY END POINTS. The primary study end point was the binary rate of restenosis in the treated segment within 6 months postintervention by computed tomography angiography (CTA) or digital subtraction angiography (DSA). Restenosis was defined as a >50% lumen diameter reduction in the worst angiographic view at the most narrow site within the limits of the treated segment plus the adjacent ten millimeters proximal and distal to the treated segment.
Secondary end points were
- anatomic outcome parameters: binary restenosis >50% by duplex ultrasonography (3, 6 and 12 months); angiographic degree of restenosis (% diameter reduction at 6 months); occurrence of stent fractures by biplane X-ray (6 and 12 months);
- clinical outcome parameters: Rutherford stage of PAD and maximum walking capacity on the treadmill (24 hours, 3, 6 and 12 months); amputation and death (until 12 months);
- hemodynamic outcome parameters: resting ankle brachial index (ABI) (24 hours, 3, 6 and 12 months).
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
- •Symptomatic peripheral artery disease Rutherford stages 3 to 5
- •>50% stenosis of the ipsilateral superficial femoral artery
- •Lesion length >30mm
- •At least one patent crural run-off vessel,
排除标准
- •Acute criticla limb ischemia
- •Previous ipsilateral bypass surgery or ipsilateral SFA stenting
- •Untreated inflow disease
- •Known intolerance to clopidogrel, aspirin or radiocontrast
结局指标
主要结局
Angiographic restenosis at 6 months
次要结局
- restenosis by duplex ultrasound at 3,6 and 12 months
- walking distance on the treadmill at 3, 6 and 12 months
- ankle brachial index at 3, 6 and 12 months
- stent fractures at 6 and 12 months