Peripheral Arterial DiseasePERSNCT04323033
Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)
A study testing PERS stent and NEPTUN C stent in people with Peripheral Arterial Disease, run by Balton Sp.zo.o. at 3 sites in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- PERS stent and NEPTUN C stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesPoland
- Study dates
- 13 Mar 2019to 9 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A.
Chrzanów, 32-500
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, 20-081
Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń
Osielsko, 86-031
About this study
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
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- PERS stent, NEPTUN C stent
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERS stentDevice
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 stentDevice
Neptun C is balloon-expanding cobalt-chromium stent.
| Study group | Role | What they receive |
|---|---|---|
| PERS stent | Experimental | 20 Patients will receive PERS stent Receives: Device: PERS stent |
| NEPTUN C stent | Active comparator | 20 Patients will receive NEPTUN C stent Receives: Device: NEPTUN C stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months FU
Secondary outcomes (8)
Vessel patency
Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler
Measured: 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.
Measured: 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.
Measured: Up to 7 days after procedure
Clinical success
Clinical success, defined as improvement in Rutherford classification for at least 1 point.
Measured: 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
Measured: 30 days and 12 months FU
Mortality rate
Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths)
Measured: 30 days, 6 months and 12 months FU
Artery patency in Duplex Doppler USG: Maximum velocity flow
Maximum velocity flow assessed by Dupplex Doppler
Measured: 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
Measured: 30 days, 6 months and 12 months FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start13 Mar 2019
- Primary completion31 Oct 2020
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balton Sp.zo.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323033
- Sponsor's protocol ID
- PERS
- Acronym
- PERS
- Status last verified
- Mar 2022
- First submitted
- 16 Oct 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04323033
- Acronym / sponsor ID
- PERS / PERS
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Balton Sp.zo.o.Industry (pharma, biotech, devices)
- Collaborators
- KCRI
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERS stent | Experimental | Device: PERS stent20 Patients will receive PERS stent |
| NEPTUN C stent | Active comparator | Device: NEPTUN C stent20 Patients will receive NEPTUN C stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERS stentPERS® 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). | Device | PERS stent |
| NEPTUN C stentNeptun C is balloon-expanding cobalt-chromium stent. | Device | NEPTUN C stent |
Primary outcome
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).
8 secondary outcomes
Vessel patency
Time frame: 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
Procedural success
Time frame: Up to 7 days after procedure
Clinical success
Time frame: During follow-up visits: 30 days, 6 months and 12 months
ABI (ankle-brachial index) change
Time frame: 30 days and 12 months FU
Mortality rate
Time frame: 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
Artery patency in Duplex Doppler USG: % of diameter stenosis
Time frame: 30 days, 6 months and 12 months FU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERS stent and NEPTUN C stent in people with Peripheral Arterial Disease, run by Balton Sp.zo.o. at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of MAE (time frame: 12 months FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.