Peripheral Artery DiseaseSUCCESS PTANCT04776434
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
A study testing SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB) in people with Peripheral Artery Disease, run by M.A. Med Alliance S.A. at 27 sites in 8 countries.
Trial summary
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 723 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 8 Feb 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject age is ≥ 18 years
- Subject is able and willing to provide informed consent
- Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.
Who cannot join
- In the opinion of the treating investigator the subject has a life expectancy of less than 12 months
- In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
Germany12 sites
Klinikum Hochsauerland
Arnsberg
Universitätsklinikum Freiburg
Bad Krozingen
Krankenhaus Buchholz
Buchholz
Universitätsklinikum Essen
Essen
DIAKO Krankenhaus
Flensburg
Medizinisches Versorgungszentrum
Hamburg
Universitätsklinikum Heidelberg
Heidelberg
SRH Klinikum Karlsbad - Langensteinbach
Langensteinbach
LMU Klinikum Campus Großhadern
München
Universitätsklinikum Tübingen
Tübingen
Grn Klinik Weinheim
Weinheim
Universitätsklinikum Würzburg
Würzburg
United Kingdom5 sites
Frimley Park Hospital
Frimley
University Hospitals of Leicester NHS Trust
Leicester
Barts Health NHS Trust (ROYAL HOSPITAL LONDON)
London
Guy's & St Thomas Hospital
London
East Surrey Hospital
Redhill
Greece3 sites
Athens Medical Center
Athens
Attikon University Hospital
Athens
General University Hospital of Patras
Pátrai
Switzerland3 sites
Kantonsspital Aarau
Aarau
Hôpitaux Universitaires de Genève (HUG)
Geneva
Luzerner Kantonsspital
Lucerne
About this study
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
Read the detailed description
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
This study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications.
Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients.
Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed.
Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion.
Data analysis will be stratified by lesion location.
- Conditions
- Peripheral Artery Disease
- Being tested
- SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)
- 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.
SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)Device
This study will capture data from the use of the SELUTION SLR according to its approved labelling.
| Study group | Role | What they receive |
|---|---|---|
| SELUTION SLR™ DEB | Experimental | Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. Receives: Device: SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Driven Target Lesion Revascularization
The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.
Measured: 1 year after treatment
Secondary outcomes (17)
Device Success
Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure.
Measured: At end of procedure
Procedure success
Device success and residual stenosis ≤50% at the end of the procedure.
Measured: At end of procedure
Clinical success
Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.
Measured: At discharge after procedure
Major Adverse Limb Events (MALE) composite endpoint
Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle).
Measured: At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
Major Cardiac Events Major Cardiac Events
MI, Stroke, Cardiovascular death
Measured: At 1, 6, 12, 24, 36,48, 60 months
Death
All-cause, cardiac, device related, procedure related
Measured: At 1, 6, 12, 24, 36, 48, 60 months
TLR
Number of Target Lesion Revascularizations
Measured: At 1, 6, 12, 24, 36, 48, 60 months
TVR
Number of Target Vessel Revascularizations
Measured: At 1, 6, 12, 24, 36, 48, 60 months
Time to first CD-TLR
Time to first Clinically Driven Target Lesion Revascularization
Measured: up to 60 months
Target limb revascularization
Number of Target limb revascularizations
Measured: At 1, 6, 12, 24, 36, 48, 60 months
Thrombosis at the target site
Number of Thrombosis at the target site
Measured: At 1 month
Amputation
Number of Amputations
Measured: up to 60 months
Rutherford Classification score
Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome.
Measured: At 6, 12, 24, 36, 48, 60 months
Ankle Brachial Index (ABI)
Change in ankle brachial index (ABI) from baseline
Measured: At 6, 12 months only
Pedal pulse
Presence of Pedal pulse
Measured: 6, 12 months only
Wound status if applicable
location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score
Measured: 6, 12 months only
Kawarada Classification score
Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease
Measured: At end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start8 Feb 2021
- Primary completion10 Nov 2024
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 723 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.A. Med Alliance S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776434
- Sponsor's protocol ID
- S2020-01
- Acronym
- SUCCESS PTA
- Status last verified
- Nov 2026
- First submitted
- 10 Feb 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
- ClinicalTrials.gov ID
- NCT04776434
- Acronym / sponsor ID
- SUCCESS PTA / S2020-01
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 723 participants (actual)
- Lead sponsor
- M.A. Med Alliance S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Mar 2021 (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.
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
Detailed description
Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).
This study will capture data from the use of the SELUTION SLR according to its approved labelling. Each indication for use will have a specific data sets in addition to generic data sets that are common across all indications.
Patients will be followed for 5 years post-procedure to obtain safety and efficacy data. A health economic analysis will be made comparing data between countries within the study and to published data for existing treatment options. Generic and disease specific Patient Reported Outcome Measures (PROMs) will be used to measure the impact of the intervention on the overall health status of patients.
Imaging data collection for patients whose standard of care includes imaging follow-up will be captured and analysed.
Data will be collected from any subject who receives a CE marked device for treatment of a peripheral (i.e. non-cardiovascular) vascular lesion.
Data analysis will be stratified by lesion location.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SELUTION SLR™ DEB | Experimental | Device: SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject age is ≥ 18 years
- Subject is able and willing to provide informed consent
- Subject is suitable for treatment with a MedAlliance SELUTION SLR DEB according to the current Instruction for use.
Key exclusion criteria (2 listed)
- In the opinion of the treating investigator the subject has a life expectancy of less than 12 months
- In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
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 |
|---|---|---|
| SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)This study will capture data from the use of the SELUTION SLR according to its approved labelling. | Device | SELUTION SLR™ DEB |
Primary outcome
Clinically Driven Target Lesion Revascularization
Time frame: 1 year after treatment
The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.
17 secondary outcomes
Device Success
Time frame: At end of procedure
Procedure success
Time frame: At end of procedure
Clinical success
Time frame: At discharge after procedure
Major Adverse Limb Events (MALE) composite endpoint
Time frame: At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
Major Cardiac Events Major Cardiac Events
Time frame: At 1, 6, 12, 24, 36,48, 60 months
Death
Time frame: At 1, 6, 12, 24, 36, 48, 60 months
TLR
Time frame: At 1, 6, 12, 24, 36, 48, 60 months
TVR
Time frame: At 1, 6, 12, 24, 36, 48, 60 months
Time to first CD-TLR
Time frame: up to 60 months
Target limb revascularization
Time frame: At 1, 6, 12, 24, 36, 48, 60 months
Thrombosis at the target site
Time frame: At 1 month
Amputation
Time frame: up to 60 months
Rutherford Classification score
Time frame: At 6, 12, 24, 36, 48, 60 months
Ankle Brachial Index (ABI)
Time frame: At 6, 12 months only
Pedal pulse
Time frame: 6, 12 months only
Wound status if applicable
Time frame: 6, 12 months only
Kawarada Classification score
Time frame: At end of procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB) in people with Peripheral Artery Disease, run by M.A. Med Alliance S.A. at 27 sites in 8 countries.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, United Kingdom, Greece, Switzerland, Argentina and 3 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinically Driven Target Lesion Revascularization (time frame: 1 year after treatment). 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 6 Nov 2026.