Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Clinical Trial Evaluating Safety and Efficacy of Cobalt-chromium Sirolimus Eluting Stent (PERS) by Balton Versus Cobalt-chromium Stent (Neptune C), to Maintain Patency of Iliac Arteries in Patients Undergoing Peripheral Angioplasty

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: PERS stent
* Device: NEPTUN C stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long. Ability to cross the lesion with guidewire (assessed during diagnostic angiography). ABI ankle-brachial index <0.9. Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4. Age ≥ 18 years. Patient signed informed consent form. Exclusion Criteria: Life expectancy less than two years. Chronic kidney disease in stage III-V. Lesion in the previously implanted by-pass. Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization. Acute lower limb ischemia. Stenosis (> 50%) or occlusion proximally to the lesion being treated. Angiographically confirmed thrombus in the lesion to be treated. Treatment requires an atherectomy to deliver stent to treated lesion. Known allergy or hypersensitivity to clopidogrel. Hemorrhagic stroke in the last three months. Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis). Pregnancy or women of childbearing potential not using effective contraception. Active inflammation at the planned access site.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PERS stent<br>20 Patients will receive PERS stent | Device: PERS stent<br>* 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).<br>|
| Active Comparator: NEPTUN C stent<br>20 Patients will receive NEPTUN C stent | Device: NEPTUN C stent<br>* Neptun C is balloon-expanding cobalt-chromium stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel patency | Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler | 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. | 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. | Up to 7 days after procedure | 
| Clinical success | Clinical success, defined as improvement in Rutherford classification for at least 1 point. | 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 | 30 days and 12 months FU | 
| Mortality rate | Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths) | 30 days, 6 months and 12 months FU | 
| Artery patency in Duplex Doppler USG: Maximum velocity flow | Maximum velocity flow assessed by Dupplex Doppler | 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 | 30 days, 6 months and 12 months FU |