NCT02033135Unknown4 期
Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Maximal walking distance
研究概览
简要总结
This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.
Research question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.
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
- •Patient has signed and dated the informed consent.
- •Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria.
- •Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.
- •Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open
- •Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
- •Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire)
- •Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect.
- •Patient has a resting ABI <0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a TBI <0.
- •Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months.
排除标准
- •Patient is pregnant, breast-feeding or under 18 years of age.
- •Patient unable to understand and sign informed consent forms
- •Patient is simultaneously participating in another investigational drug or device study.
- •Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
- •Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- •Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol.
- •Patient 2-3 patent crural vessel runoff with <50% stenosis throughout its course.
- •Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI > 40
- •Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia
结局指标
主要结局
Maximal walking distance
时间窗: 24 months
Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes.
次要结局
- Cost of the treatment(24 months)
- Ankle brachial pressure indices(24 months)
- Quality of life(24 months)
研究者
Lise Pyndt Jørgensen
MD, Ph. D. student
Rigshospitalet, Denmark
研究点 (2)
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