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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: PERS stent; Device: NEPTUN C stent

• Registration Number: NCT04323033
• Lead Sponsor: Balton Sp.zo.o.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-13
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Primary Completion: 2020-10-31
• Study Completion: 2021-11-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PERS stent	PERS stent	20 Patients will receive PERS stent
NEPTUN C stent	NEPTUN C stent	20 Patients will receive NEPTUN C stent

Primary Outcome Measures

Name	Time	Method
Occurrence of MAE	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 Outcome Measures

Name	Time	Method
Vessel patency	30 days, 6 months and 12 months FU	Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler
Success of implanting the device	Directly after implantation, at the end of endovascular index procedure	Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment.
Clinical success	During follow-up visits: 30 days, 6 months and 12 months	Clinical success, defined as improvement in Rutherford classification for at least 1 point.
ABI (ankle-brachial index) change	30 days and 12 months FU	ABI (ankle-brachial index) change after 30 days and 12 months
Mortality rate	30 days, 6 months and 12 months FU	Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)
Artery patency in Duplex Doppler USG: Maximum velocity flow	30 days, 6 months and 12 months FU	Maximum velocity flow assessed by Dupplex Doppler
Artery patency in Duplex Doppler USG: % of diameter stenosis	30 days, 6 months and 12 months FU	% of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler
Procedural success	Up to 7 days after procedure	Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE.

Trial Locations

Locations (3)

Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.; 🇵🇱 Chrzanów, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1; 🇵🇱 Lublin, Poland

Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń; 🇵🇱 Osielsko, Poland