Clinical trial NCT04776434: SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Official title: SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: M.A. Med Alliance S.A.
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 723
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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 outcomes:
measure: Clinically Driven Target Lesion Revascularization
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Device Success
timeFrame: At end of procedure
measure: Procedure success
timeFrame: At end of procedure
measure: Clinical success
timeFrame: At discharge after procedure
measure: Major Adverse Limb Events (MALE) composite endpoint
timeFrame: At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
measure: Major Cardiac Events Major Cardiac Events
timeFrame: At 1, 6, 12, 24, 36,48, 60 months
measure: Death
timeFrame: At 1, 6, 12, 24, 36, 48, 60 months
measure: TLR
timeFrame: At 1, 6, 12, 24, 36, 48, 60 months
measure: TVR
timeFrame: At 1, 6, 12, 24, 36, 48, 60 months
measure: Time to first CD-TLR
timeFrame: up to 60 months
measure: Target limb revascularization
timeFrame: At 1, 6, 12, 24, 36, 48, 60 months
measure: Thrombosis at the target site
timeFrame: At 1 month
measure: Amputation
timeFrame: up to 60 months
measure: Rutherford Classification score
timeFrame: At 6, 12, 24, 36, 48, 60 months
measure: Ankle Brachial Index (ABI)
timeFrame: At 6, 12 months only
measure: Pedal pulse
timeFrame: 6, 12 months only
measure: Wound status if applicable
timeFrame: 6, 12 months only
measure: Kawarada Classification score
timeFrame: At end of procedure
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Hospital Italiano La Plata
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland
city: Bad Krozingen
country: Germany
facility: Universitätsklinikum Freiburg
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Flensburg
country: Germany
facility: DIAKO Krankenhaus
city: Hamburg
country: Germany
facility: Medizinisches Versorgungszentrum
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Langensteinbach
country: Germany
facility: SRH Klinikum Karlsbad - Langensteinbach
city: München
country: Germany
facility: LMU Klinikum Campus Großhadern
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Weinheim
country: Germany
facility: Grn Klinik Weinheim
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Athens
country: Greece
facility: Athens Medical Center
city: Athens
country: Greece
facility: Attikon University Hospital
city: Patras
country: Greece
facility: General University Hospital of Patras
city: Tilburg
country: Netherlands
facility: Elisabeth - TweeSteden Ziekenhuis
city: Singapore
country: Singapore
facility: National University Hospital Singapore (NUHS)
city: Trnava
country: Slovakia
facility: Trnava University Hospital
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust (ROYAL HOSPITAL LONDON)
city: London
country: United Kingdom
facility: Guy's & St Thomas Hospital
city: Redhill
country: United Kingdom
facility: East Surrey Hospital
Study officials:
References: