Clinical trial NCT04323033: Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Balton Sp.zo.o.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
First posted: 2020-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Ability to cross the lesion with guidewire (assessed during diagnostic angiography).
3. ABI ankle-brachial index \<0.9.
4. Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4.
5. Age ≥ 18 years.
6. Patient signed informed consent form.

Exclusion Criteria:

1. Life expectancy less than two years.
2. Chronic kidney disease in stage III-V.
3. Lesion in the previously implanted by-pass.
4. Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization.
5. Acute lower limb ischemia.
6. Stenosis (\> 50%) or occlusion proximally to the lesion being treated.
7. Angiographically confirmed thrombus in the lesion to be treated.
8. Treatment requires an atherectomy to deliver stent to treated lesion.
9. Known allergy or hypersensitivity to clopidogrel.
10. Hemorrhagic stroke in the last three months.
11. Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis).
12. Pregnancy or women of childbearing potential not using effective contraception.
13. Active inflammation at the planned access site.

Primary outcomes:
measure: Occurrence of MAE
timeFrame: 12 months FU
Secondary outcomes:
measure: Vessel patency
timeFrame: 30 days, 6 months and 12 months FU
measure: Success of implanting the device
timeFrame: Directly after implantation, at the end of endovascular index procedure
measure: Procedural success
timeFrame: Up to 7 days after procedure
measure: Clinical success
timeFrame: During follow-up visits: 30 days, 6 months and 12 months
measure: ABI (ankle-brachial index) change
timeFrame: 30 days and 12 months FU
measure: Mortality rate
timeFrame: 30 days, 6 months and 12 months FU
measure: Artery patency in Duplex Doppler USG: Maximum velocity flow
timeFrame: 30 days, 6 months and 12 months FU
measure: Artery patency in Duplex Doppler USG: % of diameter stenosis
timeFrame: 30 days, 6 months and 12 months FU
Other outcomes:
Locations:
city: Chrzanów
country: Poland
facility: Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
city: Osielsko
country: Poland
facility: Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń
Study officials:
References: