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

Open label, real-world, prospective, multi-center, single arm, post-market surveillance study of the SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB).

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 723
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • La Plata, Argentina
    • Hospital Italiano La Plata
• Germany
  • Arnsberg, Germany
    • Klinikum Hochsauerland
  • Bad Krozingen, Germany
    • Universitätsklinikum Freiburg
  • Buchholz, Germany
    • Krankenhaus Buchholz
  • Essen, Germany
    • Universitätsklinikum Essen
  • Flensburg, Germany
    • DIAKO Krankenhaus
  • Hamburg, Germany
    • Medizinisches Versorgungszentrum
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Langensteinbach, Germany
    • SRH Klinikum Karlsbad - Langensteinbach
  • München, Germany
    • LMU Klinikum Campus Großhadern
  • Tübingen, Germany
    • Universitätsklinikum Tübingen
  • Weinheim, Germany
    • GRN Klinik Weinheim
  • Würzburg, Germany
    • Universitatsklinikum Wurzburg
• Greece
  • Athens, Greece
    • Attikon University Hospital
  • Athens, Greece
    • Athens Medical Center
  • Pátrai, Greece
    • General University Hospital of Patras
• Netherlands
  • Tilburg, Netherlands
    • Elisabeth - TweeSteden Ziekenhuis
• Singapore
  • Singapore, Singapore
    • National University Hospital Singapore (NUHS)
• Slovakia
  • Trnava, Slovakia
    • Trnava University Hospital
• Switzerland
  • Aarau, Switzerland
    • Kantonsspital Aarau
  • Geneva, Switzerland
    • Hopitaux Universitaires de Geneve (HUG)
  • Lucerne, Switzerland
    • Luzerner Kantonsspital
• United Kingdom
  • Frimley, United Kingdom
    • Frimley Park Hospital
  • Leicester, United Kingdom
    • University Hospitals of Leicester NHS Trust
  • London, United Kingdom
    • Barts Health NHS Trust (ROYAL HOSPITAL LONDON)
  • London, United Kingdom
    • Guy's & St Thomas Hospital
  • Redhill, United Kingdom
    • East Surrey Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SELUTION SLR™ DEB; Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Driven Target Lesion Revascularization	The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention.	1 year after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure.	At end of procedure
Procedure success	Device success and residual stenosis ≤50% at the end of the procedure.	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.	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).	At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
Major Cardiac Events Major Cardiac Events	MI, Stroke, Cardiovascular death	At 1, 6, 12, 24, 36,48, 60 months
Death	All-cause, cardiac, device related, procedure related	At 1, 6, 12, 24, 36, 48, 60 months
TLR	Number of Target Lesion Revascularizations	At 1, 6, 12, 24, 36, 48, 60 months
TVR	Number of Target Vessel Revascularizations	At 1, 6, 12, 24, 36, 48, 60 months
Time to first CD-TLR	Time to first Clinically Driven Target Lesion Revascularization	up to 60 months
Target limb revascularization	Number of Target limb revascularizations	At 1, 6, 12, 24, 36, 48, 60 months
Thrombosis at the target site	Number of Thrombosis at the target site	At 1 month
Amputation	Number of Amputations	up to 60 months
Rutherford Classification score	Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome.	At 6, 12, 24, 36, 48, 60 months
Ankle Brachial Index (ABI)	Change in ankle brachial index (ABI) from baseline	At 6, 12 months only
Pedal pulse	Presence of Pedal pulse	6, 12 months only
Wound status if applicable	location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score	6, 12 months only
Kawarada Classification score	Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease	At end of procedure

Collaborators and Investigators

• Sponsor: M.A. Med Alliance S.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): November 10, 2024
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: S2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No