SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction: A Randomized Controlled Trial. SUPER Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 240
- 试验地点
- 30
- 主要终点
- Maximum Walking Distance
研究概览
简要总结
The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.
It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.
详细描述
Intermittent claudication (IC) is a manifestation of cardiovascular disease, reflected by a threefold increased risk in these patients of developing serious cardiovascular events. Treatment of patients with IC is aimed at secondary prevention of cardiovascular events by control of risk factors for atherosclerotic disease, and to improve walking distance and subsequently quality of life. Supervised Exercise Therapy (SET) and Percutaneous Transluminal Angioplasty (PTA) can effectively improve pain free walking distance, but the optimal choice of treatment, specifically in patients with an iliac artery stenosis or occlusion is unclear. PTA is attractive as initial therapy since PTA of the iliac arteries has an immediate effect and it is durable. There is a lack of evidence from randomized controlled trials (RCT) to define the optimal treatment strategy for patients with IC due to iliac artery lesions; first line treatment with SET and PTA in case of failure, or immediate iliac artery PTA.
Purpose:
To define the optimal treatment strategy of IC due to an iliac artery obstruction: To start with SET and deferred PTA in case of SET failure, or immediate PTA.
Design:
Multicenter randomized controlled trial.
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 or older;
- •Disabling claudication as defined by surgeon based on patient's history;
- •Ankle/Brachial Index (ABI) < 0.9 or drop in ABI > 0.15 after exercise test;
- •Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning (CDS) (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on Magnetic Resonance Angiography (MRA) or Computed Tomography Angiography (CTA)(> 50% stenosis) or occlusion of the common or external iliac artery on CDS (PSV 0 m/s) or on MRA or CTA;
- •Iliac artery lesion and a concomitant stenosis in the superficial femoral artery defined as stenosis > 50% by CDS (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on MRA or CTA, or occlusion on CDS (PSV 0 m/s) or MRA or CTA;
- •Lesion classified A, B or C according to the TASC (TransAtlantic Inter-Society Consensus) classification of aortoiliac lesions;
- •Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline;
- •The Maximum Walking Distance on a treadmill < 300 meters.
排除标准
- •Life expectancy < 3 months;
- •Patient is unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc);
- •Patient is unable to give informed consent;
- •A documented contrast allergy;
- •Contra-indication for anticoagulant therapy;
- •Duration of current complaints < 3 months;
- •Occlusion of the common femoral artery at the affected side;
- •Patient participates in another study;
- •Heart failure or Angina Pectoris NYHA III or IV. (NYHA III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea; NYHA IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased);
- •Patient previously received Supervised Exercise Therapy (SET) according to KNGF (Dutch Society for Physiotherapists) guidelines;
- •Renal insufficiency (serum creatinin > 150 micromol/l).
研究组 & 干预措施
Intervention group: Angioplasty
Angioplasty with or without stent of the iliac artery
干预措施: Percutaneous Transluminal Angioplasty (Procedure)
Control: Supervised Exercise Therapy
Supervised exercise therapy by a physiotherapist
干预措施: Supervised Exercise Therapy (Other)
结局指标
主要结局
Maximum Walking Distance
时间窗: 12 months
Maximum walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline measured 1 year after intervention. The maximum walking distance will be assessed at baseline and 1,6,12 months follow-up.
Disease specific Quality of Life
时间窗: 12 months
Disease specific Quality of life (Qol) recorded with the disease specific VascuQol instrument 1 year after intervention. The VascuQol will be completed at baseline and 1,6,12 months follow-up.
次要结局
- Complications(During 12 months)
- Treatment failures(During 12 months)
- Painfree Walking Distance(12 months)
- Generic Quality of Life(12 months)
- Functional Status(12 months)
- Costs(During 12 months)
研究者
M.J.W. Koelemaij
Dr
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)