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

Balton Sp.zo.o.3 sites in 1 country40 target enrollmentMarch 13, 2019

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Balton Sp.zo.o.
Enrollment: 40
Locations: 3
Primary Endpoint: Occurrence of MAE
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 13, 2019

End Date

November 9, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Balton Sp.zo.o.

Responsible Party

Sponsor

Eligibility Criteria

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.
•Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to
•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.

Outcomes

Primary Outcomes

Occurrence of MAE

Time Frame: 12 months FU

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).

Secondary Outcomes

Vessel patency(30 days, 6 months and 12 months FU)
Success of implanting the device(Directly after implantation, at the end of endovascular index procedure)
Clinical success(During follow-up visits: 30 days, 6 months and 12 months)
ABI (ankle-brachial index) change(30 days and 12 months FU)
Mortality rate(30 days, 6 months and 12 months FU)
Artery patency in Duplex Doppler USG: Maximum velocity flow(30 days, 6 months and 12 months FU)
Artery patency in Duplex Doppler USG: % of diameter stenosis(30 days, 6 months and 12 months FU)
Procedural success(Up to 7 days after procedure)