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

NCT04776434 · tracked via the Priya Life Science Germany 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

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)

Facility	City	Region
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 Germany

SELUTION 4 De Novo Small Vessel IDE Trial Active, not recruiting

SELUTION4SFA Trial Active, not recruiting

SELUTION4BTK Trial Recruiting

The SELUTION DeNovo Study Active, not recruiting

Other trials for the same condition

Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease Active, not recruiting

Acotec DCB Post Market Clinical Follow-up Recruiting

BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions Active, not recruiting

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

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease 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 Germany