Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Improvement in Quality of Life scores
研究概览
简要总结
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using established surveys. Patients will be followed up 24 months after treatment. Planned recruitment and randomization of 100 patients was completed June 2015.
详细描述
Occlusive disease of the femoro-popliteal arteries is associated with symptoms ranging from pain in the calf on exertion to pain at rest and ultimately ulceration and gangrene. Treatment options include a) conservative measures, with attention to medical risk factors, smoking cessation and exercise programmes, b) minimally invasive treatments such as angioplasty and c) surgical procedures such as femoro-popliteal bypass grafts.
Percutaneous transluminal angioplasty (PTA) has been widely used in the treatment of femoro-popliteal stenosis and occlusion for many years. However, the medium and long-term results have always been suboptimal due to a high rate of restenosis.
With restenosis rates of 70 % with PTA alone in long SFA lesions. Factors which contribute to poor results include the presence of occlusion rather than stenosis, the length of the lesion and the severity of run-off vessel disease.(1)
Stents are expandable metal mesh tubes which are widely used in the treatment of arterial disease in the coronary, renal and iliac arteries, where they have been shown to have superior patency to balloon angioplasty alone.
In the treatment of SFA lesions several early studies have investigated the patency of balloon expandable stents. These are stents with low flexibility and high risk of deformation in SFA. Medium and long-term results are not better than with PTA alone.(2)
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
- •Age > 18 years
- •Female patients with child bearing potential may not be pregnant at study entry and must utilize reliable birth control for the duration of their participation in the study.
- •Patient suffering from stable claudication (Fontaine IIa and IIb).
- •One de-novo or restenotic superficial femoral artery with the target treatment area not extending beyond approximately 3 cm above the patella at MRA.
- •Patent popliteal artery on the index side, and runoff vessel situation at level six or better according to Rutherford classification prior to the day of the procedure. Target vessel diameter ≥ 4 mm at MRA.
- •Patient is willing and able to comply with the specified follow-up evaluation
- •The patient or legally authorized representative must provide written informed consent prior to the procedure.
排除标准
- •Recent hemorrhagic stroke (within past 3 months)
- •Aneurysm in the SFA or popliteal artery
- •Previously implanted stent(s) in the to be treated artery at the same site
- •Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. However, intervention to restore adequate blood flow at least three months prior to the index procedure is allowed
- •Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
- •Revascularisation involving the same limb 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure
- •8.Critical Limb Ischemia in the index leg (Fontaine III and IV). 9.Requirement of stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
- •10.Life expectancy of less than 24 months or other factors making clinical follow-up difficult 11.Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of principal investigator of this study.
- •12.Walking capacity more than 500 meters.
研究组 & 干预措施
Stenting
Active treatment group
干预措施: Stenting (Procedure)
Conservative treatment
Best medical treatment
干预措施: Best medical treatment (Other)
结局指标
主要结局
Improvement in Quality of Life scores
时间窗: 12 months
Improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys
次要结局
- Ankle/Brachial Index (ABI) and Walking Distance(24 months)