In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.
Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Infrapopliteal angioplasty using a paclitaxel coated balloon.
Infrapopliteal primary stenting using drug-eluting stent(s)
Patras University Hospital
Rio, Achaia, Greece
Angiographic Binary Restenosis
Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up
Time frame: 6 months
Technical success rate
Successful balloon angioplasty without stent use due to flow limiting dissection or/and \<30% remaining target lesion stenosis in the DCB arm and successful balloon angioplasty without flow limiting dissection or/and \<30% remaining target lesion stenosis in the DES arm.
Time frame: intra-procedural
Procedure related complication rates
procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure.
Time frame: up to 30 days
Target lesion revascularization
Clinically-driven target lesion re-intervention
Time frame: 6 months
Limb salvage
Major amputation-free interval of the treated limb at 6 months follow-up
Time frame: 6 months
Angiographic Primary Patency
Angiographically proven target lesion patency without any additional revascularization procedure
Time frame: 6 months
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