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

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

PERS stent

NEPTUN C stent

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.
Samodzielny Publiczny Szpital Kliniczny nr 1
Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PERS stent

NEPTUN C stent

Arm Description

20 Patients will receive PERS stent

20 Patients will receive NEPTUN C stent

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Vessel patency

Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler

Success of implanting the device

Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment.

Procedural success

Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE.

Clinical success

Clinical success, defined as improvement in Rutherford classification for at least 1 point.

ABI (ankle-brachial index) change

ABI (ankle-brachial index) change after 30 days and 12 months

Mortality rate

Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)

Artery patency in Duplex Doppler USG: Maximum velocity flow

Maximum velocity flow assessed by Dupplex Doppler

Artery patency in Duplex Doppler USG: % of diameter stenosis

% of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler

Full Information

NCT ID

NCT04323033

First Posted

October 16, 2019

Last Updated

March 11, 2022

Sponsor

Balton Sp.zo.o.

Collaborators

KCRI

1. Study Identification

Unique Protocol Identification Number

NCT04323033

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 13, 2019 (Actual)

Primary Completion Date

October 31, 2020 (Actual)

Study Completion Date

November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Balton Sp.zo.o.

Collaborators

KCRI

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PERS stent

Arm Type

Experimental

Arm Description

20 Patients will receive PERS stent

Arm Title

NEPTUN C stent

Arm Type

Active Comparator

Arm Description

20 Patients will receive NEPTUN C stent

Intervention Type

Device

Intervention Name(s)

PERS stent

Intervention Description

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

Intervention Name(s)

NEPTUN C stent

Intervention Description

Neptun C is balloon-expanding cobalt-chromium stent.

Primary Outcome Measure Information:

Title

Occurrence of MAE

Description

Time Frame

12 months FU

Secondary Outcome Measure Information:

Title

Vessel patency

Description

Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler

Time Frame

30 days, 6 months and 12 months FU

Title

Success of implanting the device

Description

Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment.

Time Frame

Directly after implantation, at the end of endovascular index procedure

Title

Procedural success

Description

Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE.

Time Frame

Up to 7 days after procedure

Title

Clinical success

Description

Clinical success, defined as improvement in Rutherford classification for at least 1 point.

Time Frame

During follow-up visits: 30 days, 6 months and 12 months

Title

ABI (ankle-brachial index) change

Description

ABI (ankle-brachial index) change after 30 days and 12 months

Time Frame

30 days and 12 months FU

Title

Mortality rate

Description

Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)

Time Frame

30 days, 6 months and 12 months FU

Title

Artery patency in Duplex Doppler USG: Maximum velocity flow

Description

Maximum velocity flow assessed by Dupplex Doppler

Time Frame

30 days, 6 months and 12 months FU

Title

Artery patency in Duplex Doppler USG: % of diameter stenosis

Description

% of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler

Time Frame

30 days, 6 months and 12 months FU

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

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

City

Chrzanów

ZIP/Postal Code

32-500

Country

Poland

Facility Name

Samodzielny Publiczny Szpital Kliniczny nr 1

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń

City

Osielsko

ZIP/Postal Code

86-031

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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