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

March 11, 2022 updated by: Balton Sp.zo.o.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of MAE
Time Frame: 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).
12 months FU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vessel patency
Time Frame: 30 days, 6 months and 12 months FU
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
Time Frame: Directly after implantation, at the end of endovascular index procedure
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
Time Frame: Up to 7 days after procedure
Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE.
Up to 7 days after procedure
Clinical success
Time Frame: During follow-up visits: 30 days, 6 months and 12 months
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
Time Frame: 30 days and 12 months FU
ABI (ankle-brachial index) change after 30 days and 12 months
30 days and 12 months FU
Mortality rate
Time Frame: 30 days, 6 months and 12 months FU
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
Time Frame: 30 days, 6 months and 12 months FU
Maximum velocity flow assessed by Dupplex Doppler
30 days, 6 months and 12 months FU
Artery patency in Duplex Doppler USG: % of diameter stenosis
Time Frame: 30 days, 6 months and 12 months FU
% of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler
30 days, 6 months and 12 months FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balton Sp.zo.o.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KCRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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