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

NCT04323033 | Completed

• 1 other identifier: PERS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Occurrence of MAE

  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).

  12 months FU

Secondary Outcomes (8)

• 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

• Procedural success

  Up to 7 days after 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

Study Arms (2)

PERS stent

EXPERIMENTAL

20 Patients will receive PERS stent

Device: PERS stent

NEPTUN C stent

ACTIVE COMPARATOR

20 Patients will receive NEPTUN C stent

Device: NEPTUN C stent

Interventions

PERS stent 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).

PERS stent

NEPTUN C stent DEVICE

Neptun C is balloon-expanding cobalt-chromium stent.

NEPTUN C stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Balton Sp.zo.o.: lead
• KCRI: collaborator

Study Sites (3)

Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.

Chrzanów, 32-500, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1

Lublin, 20-081, Poland

Location

Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń

Osielsko, 86-031, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: March 26, 2020
• Study Start: March 13, 2019
• Primary Completion: October 31, 2020
• Study Completion: November 9, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)