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

Critical Limb Ischemia Clinical Trial

Official title:
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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04760119
Study type	Interventional
Source	Lithuanian University of Health Sciences
Contact	Viktoras Šliaužys, M.D.
Phone	+37064297161
Email	viktoras.sliauzys@lsmuni.lt
Status	Recruiting
Phase	N/A
Start date	March 1, 2020
Completion date	January 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.