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

Peripheral Arterial Disease Clinical Trial

— PERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323033
• Other study ID #: PERS
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: November 9, 2021

Study information

• Verified date: March 2022
• Source: Balton Sp.zo.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 9, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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).
• NEPTUN C stent
Neptun C is balloon-expanding cobalt-chromium stent.

Locations

Country	Name	City	State
Poland	Malopolskie 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 Naczyn	Osielsko

Sponsors (2)

Lead Sponsor	Collaborator
Balton Sp.zo.o.	KCRI

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Procedural success	Procedural success, defined as residual stenosis =30% in angiographic assessment and lack of procedure related SAE.	Up to 7 days after procedure
Secondary	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
Secondary	ABI (ankle-brachial index) change	ABI (ankle-brachial index) change after 30 days and 12 months	30 days and 12 months FU
Secondary	Mortality rate	Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)	30 days, 6 months and 12 months FU
Secondary	Artery patency in Duplex Doppler USG: Maximum velocity flow	Maximum velocity flow assessed by Dupplex Doppler	30 days, 6 months and 12 months FU
Secondary	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