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SELUTION4SFA prøveversjon

2. november 2026 oppdatert av: M.A. Med Alliance S.A.

En prospektiv randomisert multisenter studie med enkeltblindet for å vurdere sikkerheten og effektiviteten til SELUTION SLR™ 018 medikamenteluerende ballong ved behandling av pasienter med femoropoliteale arterielesjoner

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Prospective, multi-center, single blinded, 2:1 randomized, controlled, superiority clinical trial.

This study will enroll up to 300 randomized subjects, and up to 20 subjects in a parallel pharmacokinetic (pK) sub study, at up to 60 clinical sites in the United Stated (US), Europe (EU) and Asia. A minimum of 50% of randomized subjects will be enrolled in the US. No more than 45 subjects (15% of the total randomized cohort) can be enrolled in the randomized cohort at any single investigational site.

Randomized Cohort:

Up to 300 subjects who meet all eligibility criteria will be randomized 2:1 by permuted block method (stratified by site and adjunctive lesion preparation) to one of two treatment arms:

  • Intervention - treatment with SELUTION SLR™ 018 DEB
  • Control - treatment with commercially available PTA (uncoated balloon)

Pharmacokinetic (pK) Sub-study:

The pK substudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. The separate PK substudy protocol details the schedule of evaluations and blood draws to characterize the pK plasma profile of sirolimus.

Studietype

Intervensjonell

Registrering (Faktiske)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72211
        • Arkansas Heart Hospital
    • California
      • Fremont, California, Forente stater, 94538
        • Mission Cardiovascular Research Institute
      • St. Helena, California, Forente stater, 94558
        • St. Helena Hospital
    • Colorado
      • Thornton, Colorado, Forente stater, 80023
        • ClinRé
    • Connecticut
      • Darien, Connecticut, Forente stater, 06820
        • Vascular Care Group
    • Florida
      • Bradenton, Florida, Forente stater, 34205
        • Manatee Memorial Hospital
      • Gainesville, Florida, Forente stater, 32605
        • The Cardiac and Vascular Institute Research Foundation
      • Hollywood, Florida, Forente stater, 33021
        • Memorial Healthcare System
      • Jacksonville, Florida, Forente stater, 32218
        • First Coast Cardiovascular Institute
      • Miami Beach, Florida, Forente stater, 33140
        • Palm Vascular Centers
      • Winter Park, Florida, Forente stater, 32792
        • Guardian Research Organization, LLC
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital
      • Thomasville, Georgia, Forente stater, 31792
        • Cardiovascular Consultants of South Georgia
    • Illinois
      • Park Ridge, Illinois, Forente stater, 60068
        • Advocate Lutheran General Hospital
    • Louisiana
      • Gray, Louisiana, Forente stater, 70359
        • Cardiovascular Institute of the South
    • Missouri
      • St Louis, Missouri, Forente stater, 63128
        • Mercy Hospital
    • New Jersey
      • Teaneck, New Jersey, Forente stater, 07666
        • Holy Name Medical Center
    • New York
      • The Bronx, New York, Forente stater, 10468
        • James J. Peters VA Medical Center
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27607
        • NC Heart and Vascular Research, LLC
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • Miriam Hospital
    • Tennessee
      • Tullahoma, Tennessee, Forente stater, 37388
        • Tennessee Center for Clinical Trials
    • Texas
      • El Paso, Texas, Forente stater, 79902
        • El Paso Cardiology
      • Houston, Texas, Forente stater, 77030
        • Baylor College of Medicine
      • Plano, Texas, Forente stater, 75093
        • Heart Hospital Baylor Plano
  • Hong Kong
      • Shatin, Hong Kong
        • The Chinese University of Hong Kong
    • Pok Fu Lam
      • Hong Kong, Pok Fu Lam, Hong Kong
        • Queen Mary Hospital
  • Tyskland
      • Arnsberg, Tyskland, 59759
        • Alexianer Klinikum Hochsauerland
      • Bad Krozingen, Tyskland, 79189
        • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      • Buchholz, Tyskland, 21244
        • Krankenhaus Buchholz
      • Coburg, Tyskland, 96450
        • Sana Kliniken Oberfranken Coburg
      • Leipzig, Tyskland, 04103
        • Universitätsklinikum Leipzig
      • Rosenheim, Tyskland, 83022
        • RoMed Klinikum Rosenheim
      • Tübingen, Tyskland, 72076
        • University Clinic Tübingen
  • Østerrike
      • Graz, Østerrike, A-8036
        • Universitätsklinikum Graz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Clinical Inclusion Criteria:

  1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
  2. Life expectancy >1 year in opinion of investigator.
  3. Documented ischemia with Rutherford classification category 2, 3 or 4.
  4. Target lesion(s) in the SFA or PPA.
  5. Able to walk without the assistance of a walker.
  6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
  7. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment.

Angiographic Inclusion Criteria:

  1. Angiographic evidence that target lesion lies within the superficial femoral artery and/or proximal popliteal artery (P1 and P2 only).

  2. Angiographic evidence that the target lesion consists of either a de novo lesion or a non-stented restenotic lesion, or a combination of both, that meets one of the following criteria:

    A. A stenosis of 70-99% with lesion length between ≥3cm and <20cm by visual estimation.

    B. A total (100%) occlusion with lesion length between ≥3cm and ≤10cm by visual estimation.

    C. A combination lesion (stenosis and total occlusion) must have a total lesion length between ≥3cm and <20cm by visual estimation with an occluded segment that is ≤10cm by visual estimation.

    D. If multiple lesions are to be treated, then only 2 lesions may be included. The total combination of lengths must be between ≥3cm and < 20cm by visual estimation, and there must be at least 5 cm of artery that is not to be treated between them.

  3. Target vessel reference diameter ≥4mm and ≤7mm.

  4. Patent arterial inflow (common iliac, external iliac, common femoral and profunda femoris arteries, and the proximal 2 cm of the SFA) free from significant lesion (defined as ≥50% stenosis) as confirmed on angiography.

    Note: Where required, inflow iliac arteries (common and external iliac arteries only) must be successfully treated during the index procedure. Completion angiography must confirm successful treatment of inflow disease (≤30% residual stenosis, no distal embolization, and no Grade C or greater dissection ) prior to pre-dilation and randomization of the target lesion(s). Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries.

  5. Angiographic evidence of adequate distal run off (defined as ≤50% stenosis) in one or more tibial arteries on initial angiography, and if applicable, after completion of inflow artery treatment.

Note: Treatment of outflow disease is permitted during the index procedure. Drug-eluting devices are not allowed for outflow treatment.

PK Sub-Study Inclusion Criteria:

Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:

1. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations.

Clinical Exclusion Criteria:

  1. Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography.
  2. Inability to tolerate dual antiplatelet therapy.
  3. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated.
  4. Stroke or MI within 3 months of enrollment.
  5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia).
  6. Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure.
  7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.
  8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease)
  9. Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device).
  10. Subject has target lesion(s) that require treatment via pedal site.
  11. Subject has target lesion(s) that require access via upper extremity arteries.
  12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter.
  13. Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
  14. Systemic infection (WBC > 12,000 and febrile) or known immune compromise.
  15. Breast-feeding woman.
  16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.

Angiographic Exclusion Criteria:

  1. Presence of a previously placed stent in the treated artery.
  2. Failure to successfully cross the target lesion.
  3. Residual stenosis ≥30% after pre-dilatation.

PK Sub-Study Exclusion Criteria:

  1. Subjects must meet none of the main protocol exclusion criteria (Section 6.1.2 of the main protocol) to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met:
  2. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure.
  3. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures >30 days after index procedure (Exclusion #20 and #22 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study.
  4. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason.
  5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir.
  6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SELUTION SLR™ 018 DEB

Treatment with Selution SLR drug eluting balloon to apply long term (>90 days) local treatment with sirolimus
Enhet: SELUTION SLR™ 018 DEB

a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.
Aktiv komparator: Plain (Uncoated) Balloon Angioplasty (PTA)

Opening artery only by dilatation with an temporary inserted and inflated balloon.
Enhet: Plain (Uncoated) Balloon Angioplasty (PTA)

a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Efficacy Endpoint
Tidsramme: 12 months

The primary efficacy endpoint is primary patency of the target lesion defined as freedom from ALL of the following outcomes evaluated at 12 months post procedure:

  • Clinically driven target lesion revascularization (CD-TLR, defined as re-intervention of target lesion(s) due to recurrent, persistent, or worsening symptoms and angiographic restenosis (≥ 50% diameter stenosis) of target lesion by ACL measurement) and
  • Restenosis as determined by core lab adjudicated duplex ultrasound peak systolic velocity ratio of >2.4 or occlusion of the target lesion.
12 months
Primary Safety Endpoint
Tidsramme: 30 days or 12 months

The primary safety endpoint is the freedom from ALL of the following adverse events:

  • All-cause perioperative death (POD) [evaluated at 30 days] and
  • Target limb major (above-the-ankle) amputation [evaluated at 12 months] and
  • Clinically driven target lesion revascularization (CD-TLR) [evaluated at 12 months]
30 days or 12 months
PK Sub-Study Primary Endpoint
Tidsramme: 6 months

The primary endpoints of the sub-study are the PK parameters of C(max), T(max), AUC(last), and MRT(last) that will be used to determine the pharmacokinetic profile of Sirolimus after administration of the SELUTION SLR 018 DEB.
6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Powered Secondary Endpoints
Tidsramme: 12 months

If both primary endpoints are met, the following endpoint will be tested for superiority in a sequential manner:

• Clinically driven target lesion revascularization (CD-TLR) [evaluated at 12 months]
12 months
Secondary Performance Endpoints
Tidsramme: Immediately following the procedure
  • Device success, defined as successful delivery, balloon inflation, deflation, and retrieval of the intact investigational device [evaluated post-procedure].
  • Procedural (technical) success, defined as device success and residual diameter stenosis ≤ 30% on completion angiography by core lab assessment [evaluated post-procedure].
  • Clinical success, defined as procedural success without procedural complications (death, above-ankle target limb amputation, thrombosis of the target lesion or TLR) prior to discharge (evaluated at discharge defined as immediately prior to hospital discharge from the index procedure or within 7 days, whichever occurs first).
Immediately following the procedure
Secondary Safety Endpoints
Tidsramme: 1, 6, and 12 months, and 2-5 years
  • Major adverse limb events (MALE): Major adverse limb events (MALE), defined as the composite of major (above-the-ankle) amputation or major reintervention (new bypass graft, jump/interposition graft revision, thrombectomy/thrombolysis) of the index limb.
  • Major cardiovascular events: defined as the composite of cardiovascular death, myocardial infarction (MI), and stroke.
  • All-cause mortality.
  • Major amputation, defined as above-the-ankle amputation of the target limb.
  • Amputation-free survival, defined as freedom from all-cause mortality and major amputation.
  • Target lesion thrombosis by angiographic or DUS core laboratory adjudication
1, 6, and 12 months, and 2-5 years
Secondary Efficacy Endpoints
Tidsramme: 1, 6, and 12 months, and 2-5 years

The following exploratory secondary endpoints will be assessed at discharge and at 1, 6, and 12 months, and 2-5 years (unless otherwise indicated). Detailed descriptions of these endpoints are provided individually under the corresponding Secondary Outcome Measures:

  • Primary sustained clinical improvement
  • Secondary sustained clinical improvement
  • Lesion primary patency
  • Lesion Primary assisted patency
  • Lesion secondary-assisted patency
  • Freedom from CD-TLR and binary restenosis
  • Any TLR
  • CD-TLR
  • Clinically driven Target Vessel Revascularization (TVR)
  • Change in Rutherford category
  • Change in ankle brachial index (ABI)
  • Change in Walking capacity assessed by Walking Impairment Questionnaire (WIQ)
1, 6, and 12 months, and 2-5 years
Primary sustained clinical improvement
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as freedom from target limb major amputation and CD-TLR AND increase in Rutherford category from baseline.
1, 6, and 12 months, and 2-5 years
Secondary sustained clinical improvement
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as freedom from target limb major amputation AND increase in Rutherford category from baseline.

  • Major amputation, defined as above-the-ankle amputation of the target limb.
  • Amputation-free survival, defined as freedom from all-cause mortality and major amputation.
1, 6, and 12 months, and 2-5 years
Lesion primary patency
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as freedom from lesion re-intervention AND freedom from a DS >50% restenosis assessed by Core Lab, using by order of preference (1) angiography, (2) CT, (3) MRA, (4) DUS (as determined by a DUS peak systolic velocity ratio [PSVR] of ≤ 2.4)
1, 6, and 12 months, and 2-5 years
Lesion Primary assisted patency
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as freedom from a DS>50% restenosis assessed by Core Lab, using by order of preference (1) angiography, (2) CT, (3) MRA, (4) DUS (as determined by a DUS peak systolic velocity ratio PSVR of ≤ 2.4) - irrespective of interventions for stenoses. Lesion Secondary patency, defined as freedom from lesion re-intervention, AND freedom from permanent occlusion (at the last follow-up imaging) assessed by Core Lab, using by order of preference (1) angiography, (2) CT, (3) MRA, (4) DUS.
1, 6, and 12 months, and 2-5 years
Lesion secondary-assisted patency
Tidsramme: 12 and 24 months

A secondary efficacy endpoint defined as freedom from permanent occlusion (at the last follow-up imaging) assessed by Core Lab, using by order of preference (1) angiography, (2) CT, (3) MRA, (4) DUS - irrespective of interventions for stenoses
12 and 24 months
Freedom from CD-TLR and binary restenosis
Tidsramme: 1, 3, 6, 12, 24, 36 months

A secondary efficacy endpoint as determined by the DCL [at 1, 3, 6, 12, 24, 36 months]
1, 3, 6, 12, 24, 36 months
Any TLR
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as any re-intervention of target lesion(s).
1, 6, and 12 months, and 2-5 years
CD-TLR
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as re-intervention of target lesion(s) due to recurrent/persistent/worsening symptoms and the angiographic finding of ≥ 50% restenosis of target lesion by ACL measurement.
1, 6, and 12 months, and 2-5 years
Clinically driven Target Vessel Revascularization (TVR)
Tidsramme: 1, 6, and 12 months, and 2-5 years

A secondary efficacy endpoint defined as re-intervention of target vessel due to recurrent/persistent/worsening symptoms and the angiographic finding of ≥ 50% restenosis of target vessel by ACL measurement.
1, 6, and 12 months, and 2-5 years
Change in Rutherford category
Tidsramme: 1, 6, 12, 24 and 36 months

A secondary efficacy endpoint from baseline [at 1, 6, 12, 24 and 36 months]
1, 6, 12, 24 and 36 months
Change in ankle brachial index (ABI)
Tidsramme: 12 and 24 months

A secondary efficacy endpoint defined as change in ankle brachial index (ABI) from baseline.
12 and 24 months
Change in Walking capacity assessed by Walking Impairment Questionnaire (WIQ)
Tidsramme: 1, 6, 12, 24 and 36 months

A secondary efficacy endpoint defined as change in Walking capacity assessed by Walking Impairment Questionnaire (WIQ) from baseline.
1, 6, 12, 24 and 36 months
Secondary Imaging endpoints (DCL adjudicated):
Tidsramme: 12 and 24 months
  • Primary duplex-defined binary restenosis - Peak Systolic Velocity Ratio (PSVR)>2.4.
  • Alternate duplex-defined binary restenosis - Peak Systolic Velocity Ratio (PSVR)>3.4.
12 and 24 months
Secondary Quality of life and health economic assessments (1)
Tidsramme: 12 months

• Change in EQ-5D score from baseline. OBS.: Following EuroQol terminology: Scores are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.
12 months
Secondary Quality of life and health economic assessments (2)
Tidsramme: 12 months

• Days of target lesion-related hospitalization at 12 months.
12 months
PK Sub-Study Secondary Endpoint
Tidsramme: 6 months

If calculations are valid, additional PK parameters of AUC(inf), Cl, Vz, Vss, and half-life. Other PK parameters such as dose normalized Cmax and AUC will be considered if appropriate.
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

M.A. Med Alliance S.A.

Samarbeidspartnere

NAMSA
Cordis US Corp.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2022

Primær fullføring (Faktiske)

25. juli 2026

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

12. november 2021

Først innsendt som oppfylte QC-kriteriene

12. november 2021

Først lagt ut (Faktiske)

24. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • S2020-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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