NCT04776434

Brief 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).

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
723

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
8 countries

27 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Feb 2021Dec 2028

Study Start

First participant enrolled

February 8, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

February 10, 2021

Last Update Submit

September 22, 2025

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • Device Success

    At end of procedure

  • Procedure success

    At end of procedure

  • Clinical success

    At discharge after procedure

  • Major Adverse Limb Events (MALE) composite endpoint

    At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months

  • Major Cardiac Events Major Cardiac Events

    At 1, 6, 12, 24, 36,48, 60 months

  • +12 more secondary outcomes

Study Arms (1)

SELUTION SLR™ DEB

EXPERIMENTAL

Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter.

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

Interventions

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.

SELUTION SLR™ DEB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Hospital Italiano La Plata

La Plata, Argentina

Location

Klinikum Hochsauerland

Arnsberg, Germany

Location

Universitätsklinikum Freiburg

Bad Krozingen, Germany

Location

Krankenhaus Buchholz

Buchholz, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

DIAKO Krankenhaus

Flensburg, Germany

Location

Medizinisches Versorgungszentrum

Hamburg, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

SRH Klinikum Karlsbad - Langensteinbach

Langensteinbach, Germany

Location

LMU Klinikum Campus Großhadern

München, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Grn Klinik Weinheim

Weinheim, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Athens Medical Center

Athens, Greece

Location

Attikon University Hospital

Athens, Greece

Location

General University Hospital of Patras

Pátrai, Greece

Location

Elisabeth - TweeSteden Ziekenhuis

Tilburg, Netherlands

Location

National University Hospital Singapore (NUHS)

Singapore, Singapore

Location

Trnava University Hospital

Trnava, Slovakia

Location

Kantonsspital Aarau

Aarau, Switzerland

Location

Hôpitaux Universitaires de Genève (HUG)

Geneva, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Frimley Park Hospital

Frimley, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Barts Health NHS Trust (ROYAL HOSPITAL LONDON)

London, United Kingdom

Location

Guy's & St Thomas Hospital

London, United Kingdom

Location

East Surrey Hospital

Redhill, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2021

First Posted

March 1, 2021

Study Start

February 8, 2021

Primary Completion

November 10, 2024

Study Completion (Estimated)

December 31, 2028

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

SG(1)SL(1)GR(3)NL(1)GB(5)DE(12)AR(1)CH(3)