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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critical Limb Ischemia
- Sponsor
- Lithuanian University of Health Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Primary, primary-assisted and secondary patency
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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: A. Vein bypass surgery first strategy B. Endovascular treatment first (drug coated balloon angioplasty) strategy Outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. Information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy.
Investigators
Viktoras Šliaužys
M.D.
Lithuanian University of Health Sciences
Eligibility Criteria
Inclusion Criteria
- •Patient with type 2 diabetes mellitus
- •Severe limb ischemia (Rutherford class \>=4) due to infrapopliteal, +/- popliteal disease \[ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; \>40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.\]
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Primary, primary-assisted and secondary patency
Time Frame: 24 months
Clinical and ultrasound assesment
Secondary Outcomes
- 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)