SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
- Conditions
- Peripheral Artery Disease
- Registration Number
- NCT04776434
- Lead Sponsor
- M.A. Med Alliance S.A.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 723
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Procedure success At end of procedure Device success and residual stenosis ≤50% at the end of the procedure.
Device Success At end of procedure Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure.
Major Adverse Limb Events (MALE) composite endpoint At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months Severe limb ischemia leading to an intervention or major vascular amputation (above the ankle).
Pedal pulse 6, 12 months only Presence of Pedal pulse
Clinical success At discharge after procedure Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge.
Thrombosis at the target site At 1 month Number of Thrombosis at the target site
Amputation up to 60 months Number of Amputations
Ankle Brachial Index (ABI) At 6, 12 months only Change in ankle brachial index (ABI) from baseline
Wound status if applicable 6, 12 months only location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score
Major Cardiac Events Major Cardiac Events At 1, 6, 12, 24, 36,48, 60 months MI, Stroke, Cardiovascular death
TVR At 1, 6, 12, 24, 36, 48, 60 months Number of Target Vessel Revascularizations
Time to first CD-TLR up to 60 months Time to first Clinically Driven Target Lesion Revascularization
Target limb revascularization At 1, 6, 12, 24, 36, 48, 60 months Number of Target limb revascularizations
Rutherford Classification score At 6, 12, 24, 36, 48, 60 months Change in Rutherford Classification score from baseline (Scale from 0 to 6, higher score means worse outcome.
Death At 1, 6, 12, 24, 36, 48, 60 months All-cause, cardiac, device related, procedure related
TLR At 1, 6, 12, 24, 36, 48, 60 months Number of Target Lesion Revascularizations
Kawarada Classification score At end of procedure Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease
Trial Locations
- Locations (27)
Hospital Italiano La Plata
🇦🇷La Plata, Argentina
Universitätsklinikum Freiburg
🇩🇪Bad Krozingen, Germany
Krankenhaus Buchholz
🇩🇪Buchholz, Germany
Grn Klinik Weinheim
🇩🇪Weinheim, 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
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Athens Medical Center
🇬🇷Athens, Greece
Attikon University Hospital
🇬🇷Athens, Greece
General University Hospital of Patras
🇬🇷Patras, 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)
🇨🇭Geneve, Switzerland
Luzerner Kantonsspital
🇨🇭Luzern, 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
Klinikum Hochsauerland
🇩🇪Arnsberg, Germany