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Clinical Trials in the UK / NCT04776434
Active, not recruiting Not applicable

SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study

NCT04776434 · tracked via the Priya Life Science UK tracker
Sponsor
M.A. Med Alliance S.A
Phase
Not applicable
Started
2021-02-08
Last updated
2025-09-23

Condition(s) studied

Peripheral Artery Disease

Investigational drug(s) / intervention(s)

SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Clinically Driven Target Lesion Revascularization — 1 year after treatment
    The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.

Trial sites (27)

FacilityCityRegionStatus
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

More M.A. Med Alliance S.A. trials in the UK

The SELUTION DeNovo Study Active, not recruiting

Other trials for the same condition

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04776434 on ClinicalTrials.gov ↗ ← All trials in the UK