The aim of this study is to assess the safety and efficacy of PAD treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon PERS (CoCr SES) compared to cobalt-chromium balloon-expandable (Neptun C) stent (CoCr BMS) in patients with symptomatic iliac arteries disease requiring revascularization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
PERS® is a cobalt-chromium stent, made of cobalt-chromium alloy with drug (Sirolimus) and biodegradable polymer controlling drug elution. The length of the stent is selected to cover the treated lesion with a margin of 5 mm proximal and distal, while the diameter of the stent will be selected based on the QVA measurement (balloon to vessel ratio 1:1).
Neptun C is balloon-expanding cobalt-chromium stent.
Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.
Chrzanów, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, Poland
Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń
Osielsko, Poland
Occurrence of MAE
Occurrence of major adverse event (MAE) in 12 months follow up, defined as death related to stent implantation of procedure, amputation above metatarsus in treated limb due to vascular complication or/and reintervention in treated lesion (TLR).
Time frame: 12 months FU
Vessel patency
Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler
Time frame: 30 days, 6 months and 12 months FU
Success of implanting the device
Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment.
Time frame: Directly after implantation, at the end of endovascular index procedure
Procedural success
Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE.
Time frame: Up to 7 days after procedure
Clinical success
Clinical success, defined as improvement in Rutherford classification for at least 1 point.
Time frame: During follow-up visits: 30 days, 6 months and 12 months
ABI (ankle-brachial index) change
ABI (ankle-brachial index) change after 30 days and 12 months
Time frame: 30 days and 12 months FU
Mortality rate
Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)
Time frame: 30 days, 6 months and 12 months FU
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Artery patency in Duplex Doppler USG: Maximum velocity flow
Maximum velocity flow assessed by Dupplex Doppler
Time frame: 30 days, 6 months and 12 months FU
Artery patency in Duplex Doppler USG: % of diameter stenosis
% of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler
Time frame: 30 days, 6 months and 12 months FU