Status:
UNKNOWN
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
Lead Sponsor:
Lithuanian University of Health Sciences
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04760119
Start Date
March 1 2020
End Date
January 1 2024
Last Update
February 18 2021
Active Locations (1)
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1
Lithuanian University of Health Sciences
Kaunas, LT, Lithuania, 50161