Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Primary, primary-assisted and secondary patency
研究概览
简要总结
The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.
详细描述
Objective: To consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (DPN).
All patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered.
To be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. If the patient is suitable for both treatment arms, they will be invited to enter the trial.
If patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission
Patient will be randomised to one of the following groups:
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
盲法说明
Blinding is not possible due to the completely different natures of the treatments allocated.
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 with type 2 diabetes mellitus
- •Severe limb ischemia (Rutherford class >=4) due to infrapopliteal, +/- popliteal disease [ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; >40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.]
排除标准
- •Requires primary limb amputation
- •Acute limb ischemia
- •Anticipated life expectancy of <2 years
- •Unsuitable for either revascularisation strategy
- •Severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)
结局指标
主要结局
Primary, primary-assisted and secondary patency
时间窗: 24 months
Clinical and ultrasound assesment
次要结局
- Ankle-brachial index (ABI)(24 months)
- Toe-brachial index (TBI)(24 months)
- Transcutaneous oxygen tension (TcPO2)(24 months)
- Healing of tissue loss (ulcers, gangrene)(24 months)
- Re- and cross-over intervention rates(24 months)
- Ischemic symptoms(24 months)
- In-hospital morbidity/mortality and overall survival(24 months)
- Diabetic neuropathy dinamics: clinical examination of foot sensation(24 months)
- Diabetic neuropathy dinamics: neurometer(24 months)
- Diabetic neuropathy dinamics: electroneuromiography(24 months)
- Major and minor amputation rates(24 months)
- Relief of pain: Visual analog scale (VAS)(24 months)
- Quality of life: EQ-5D-5L questionaire(24 months)
研究者
Viktoras Šliaužys
M.D.
Lithuanian University of Health Sciences