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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: PERS stent; Device: NEPTUN C stent

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Chrzanów, Poland, 32-500
    • Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.
  • Lublin, Poland, 20-081
    • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Osielsko, Poland, 86-031
    • Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PERS stent; 20 Patients will receive PERS stent	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).
ACTIVE_COMPARATOR: NEPTUN C stent; 20 Patients will receive NEPTUN C stent	Device: NEPTUN C stent; Neptun C is balloon-expanding cobalt-chromium stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Balton Sp.zo.o.
• Collaborators: KCRI

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 13, 2019
• Primary Completion (ACTUAL): October 31, 2020
• Study Completion (ACTUAL): November 9, 2021

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: PERS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No