Swedish Drug-elution Trial in Peripheral Arterial Disease - a Multicenter, Prospective Randomized Controlled Clinical Trial Based on the Swedish Vascular Registry (SWEDVASC) Platform
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,556
- 试验地点
- 2
- 主要终点
- Health-related quality of life (SWEDEPAD 2)
研究概览
简要总结
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).
In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.
In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 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
- Single (Participant)
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
- •All adults > 18 years old willing to be randomized
- •Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications
排除标准
- •Acute thromboembolic disease in the leg
- •Infrainguinal aneurysmal disease
- •Previous participation in the study or in other randomised interventional study of infrainguinal lesions
- •Patients without a Swedish personal identification number
结局指标
主要结局
Health-related quality of life (SWEDEPAD 2)
时间窗: Assessed one year after randomization
Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD.
Amputation rate (SWEDEPAD 1)
时间窗: Assessed when all patients have been followed for at least one year
Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year.
次要结局
- Amputation-free survival(Assessed when all participants have been followed for at least one, three and five years.)
- Target lesion revascularization (TLR)(Assessed one year after the intervention and when all participants have been followed for one, three and five years.)
- Patency(Assessed after 1 month and 1 year)
- Health-related quality of life (SWEDEPAD 1)(Assessed after one year following randomisation)
- Survival(Assessed when all participants have been followed for at least one, three and five years.)
- Health-economic assessment(Assessed one year after the intervention and when all participants have been followed for one, three and five years)
- Time to target lesion revascularization(Assessed one year after the intervention and when all participants have been followed for one, three and five years.)
- Amputation rate (SWEDEPAD 2)(Assessed one year after the intervention and when all participants have been followed for one, three and five years)
- Improvement in clinical symptoms, assessed with the Rutherford classification(Assessed after one month and one year)
研究者
Mårten Falkenberg
MD, PhD
Sahlgrenska University Hospital