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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2021-11-09

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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PERS stent

20 Patients will receive PERS stent

Group Type EXPERIMENTAL

PERS stent

Intervention Type DEVICE

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).

NEPTUN C stent

20 Patients will receive NEPTUN C stent

Group Type ACTIVE_COMPARATOR

NEPTUN C stent

Intervention Type DEVICE

Neptun C is balloon-expanding cobalt-chromium stent.

Interventions

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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).

Intervention Type DEVICE

NEPTUN C stent

Neptun C is balloon-expanding cobalt-chromium stent.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No