SUCCES (udvalg, sikkerhed, effektivitet, sundhedsøkonomi og promS) PTA-undersøgelse (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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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La Plata, Argentina
- Hospital Italiano La Plata
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Frimley, Det Forenede Kongerige
- Frimley Park Hospital
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Leicester, Det Forenede Kongerige
- University Hospitals of Leicester NHS Trust
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London, Det Forenede Kongerige
- Barts Health NHS Trust (ROYAL HOSPITAL LONDON)
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London, Det Forenede Kongerige
- Guy's & St Thomas Hospital
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Redhill, Det Forenede Kongerige
- East Surrey Hospital
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Athens, Grækenland
- Attikon University Hospital
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Athens, Grækenland
- Athens Medical Center
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Pátrai, Grækenland
- General University Hospital of Patras
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Tilburg, Holland
- Elisabeth - TweeSteden Ziekenhuis
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Aarau, Schweiz
- Kantonsspital Aarau
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Geneva, Schweiz
- Hôpitaux Universitaires de Genève (HUG)
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Lucerne, Schweiz
- Luzerner Kantonsspital
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Singapore, Singapore
- National University Hospital Singapore (NUHS)
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Trnava, Slovakiet
- Trnava University Hospital
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Arnsberg, Tyskland
- Klinikum Hochsauerland
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Bad Krozingen, Tyskland
- Universitätsklinikum Freiburg
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Buchholz, Tyskland
- Krankenhaus Buchholz
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Essen, Tyskland
- Universitätsklinikum Essen
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Flensburg, Tyskland
- DIAKO Krankenhaus
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Hamburg, Tyskland
- Medizinisches Versorgungszentrum
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Heidelberg, Tyskland
- Universitätsklinikum Heidelberg
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Langensteinbach, Tyskland
- SRH Klinikum Karlsbad - Langensteinbach
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München, Tyskland
- LMU Klinikum Campus Großhadern
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Tübingen, Tyskland
- Universitätsklinikum Tübingen
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Weinheim, Tyskland
- Grn Klinik Weinheim
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Würzburg, Tyskland
- Universitätsklinikum Würzburg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: SELUTION SLR™ DEB
Med Alliance SELUTION SLR™ 018 DEB Sirolimus Eluting Balloon Catheter. |
This study will capture data from the use of the SELUTION SLR according to its approved labelling. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinically Driven Target Lesion Revascularization
Tidsramme: 1 year after treatment
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The primary endpoint will be freedom from Clinically Driven Target Lesion Revascularisation (CD-TLR) at 1-year post-intervention. |
1 year after treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Device Success
Tidsramme: At end of procedure
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Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure. |
At end of procedure
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Procedure success
Tidsramme: At end of procedure
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Device success and residual stenosis ≤50% at the end of the procedure. |
At end of procedure
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Clinical success
Tidsramme: At discharge after procedure
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Procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion or TLR) prior to discharge. |
At discharge after procedure
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Major Adverse Limb Events (MALE) composite endpoint
Tidsramme: At discharge after procedure and 1, 6, 12, 24, 36, 48 and 60 months
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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
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Major Cardiac Events Major Cardiac Events
Tidsramme: At 1, 6, 12, 24, 36,48, 60 months
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MI, Stroke, Cardiovascular death |
At 1, 6, 12, 24, 36,48, 60 months
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Death
Tidsramme: At 1, 6, 12, 24, 36, 48, 60 months
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All-cause, cardiac, device related, procedure related |
At 1, 6, 12, 24, 36, 48, 60 months
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TLR
Tidsramme: At 1, 6, 12, 24, 36, 48, 60 months
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Number of Target Lesion Revascularizations |
At 1, 6, 12, 24, 36, 48, 60 months
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TVR
Tidsramme: At 1, 6, 12, 24, 36, 48, 60 months
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Number of Target Vessel Revascularizations |
At 1, 6, 12, 24, 36, 48, 60 months
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Time to first CD-TLR
Tidsramme: up to 60 months
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Time to first Clinically Driven Target Lesion Revascularization |
up to 60 months
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Target limb revascularization
Tidsramme: At 1, 6, 12, 24, 36, 48, 60 months
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Number of Target limb revascularizations |
At 1, 6, 12, 24, 36, 48, 60 months
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Thrombosis at the target site
Tidsramme: At 1 month
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Number of Thrombosis at the target site |
At 1 month
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Amputation
Tidsramme: up to 60 months
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Number of Amputations |
up to 60 months
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Rutherford Classification score
Tidsramme: At 6, 12, 24, 36, 48, 60 months
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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
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Ankle Brachial Index (ABI)
Tidsramme: At 6, 12 months only
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Change in ankle brachial index (ABI) from baseline |
At 6, 12 months only
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Pedal pulse
Tidsramme: 6, 12 months only
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Presence of Pedal pulse |
6, 12 months only
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Wound status if applicable
Tidsramme: 6, 12 months only
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location, size, infection, status, Wound, Ischemia and Foot Infection (WIfI) classification system score |
6, 12 months only
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Kawarada Classification score
Tidsramme: At end of procedure
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Change from baseline to end of procedure to assess change in severity of Pedal Artery Disease |
At end of procedure
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S2020-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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