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

NCT04323033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-14

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

PERS stent

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).

DEVICE

NEPTUN C stent

Neptun C is balloon-expanding cobalt-chromium stent.

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Balton Sp.zo.o.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2020-10-31
Completion
2021-11-09

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04323033 on ClinicalTrials.gov