Status:
COMPLETED
Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)
Lead Sponsor:
Balton Sp.zo.o.
Collaborating Sponsors:
KCRI
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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) c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04323033
Start Date
March 13 2019
End Date
November 9 2021
Last Update
March 14 2022
Active Locations (3)
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1
Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.
Chrzanów, Poland, 32-500
2
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, Poland, 20-081
3
Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń
Osielsko, Poland, 86-031