SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
NCT ID: NCT04776434
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
723 participants
INTERVENTIONAL
2021-02-08
2028-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SELUTION SLR™ DEB
Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* In the opinion of the treating investigator the subject is unlikely to comply with the study follow-up regime
18 Years
ALL
No
Sponsors
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M.A. Med Alliance S.A.
INDUSTRY
Responsible Party
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Locations
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Hospital Italiano La Plata
La Plata, , Argentina
Klinikum Hochsauerland
Arnsberg, , Germany
Universitätsklinikum Freiburg
Bad Krozingen, , Germany
Krankenhaus Buchholz
Buchholz, , Germany
Universitätsklinikum Essen
Essen, , Germany
DIAKO Krankenhaus
Flensburg, , Germany
Medizinisches Versorgungszentrum
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
SRH Klinikum Karlsbad - Langensteinbach
Langensteinbach, , Germany
LMU Klinikum Campus Großhadern
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Grn Klinik Weinheim
Weinheim, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Athens Medical Center
Athens, , Greece
Attikon University Hospital
Athens, , Greece
General University Hospital of Patras
Pátrai, , Greece
Elisabeth - TweeSteden Ziekenhuis
Tilburg, , Netherlands
National University Hospital Singapore (NUHS)
Singapore, , Singapore
Trnava University Hospital
Trnava, , Slovakia
Kantonsspital Aarau
Aarau, , Switzerland
Hôpitaux Universitaires de Genève (HUG)
Geneva, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
Frimley Park Hospital
Frimley, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Barts Health NHS Trust (ROYAL HOSPITAL LONDON)
London, , United Kingdom
Guy's & St Thomas Hospital
London, , United Kingdom
East Surrey Hospital
Redhill, , United Kingdom
Countries
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Other Identifiers
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S2020-01
Identifier Type: -
Identifier Source: org_study_id
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