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
NCT ID: NCT04760119
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-03-01
2024-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vein bypass surgery first strategy
Vein bypass surgery first strategy
Vein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed.
Endovascular treatment first (drug coated balloon angioplasty) strategy
Endovascular treatment first (drug coated balloon angioplasty) strategy
Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated.
Interventions
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Vein bypass surgery first strategy
Vein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed.
Endovascular treatment first (drug coated balloon angioplasty) strategy
Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Lithuanian University of Health Sciences
OTHER
Responsible Party
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Viktoras Šliaužys
M.D.
Locations
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Lithuanian University of Health Sciences
Kaunas, LT, Lithuania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VS3005
Identifier Type: -
Identifier Source: org_study_id
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