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The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion (DEScover)

1. oktober 2026 opdateret af: Scitech Produtos Medicos SA

Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Sirolimus-Eluting Covered Stent in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients

The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris Drug-Eluting Covered Stent (Solaris DE) in the treatment of stenosis or occlusion within the outflow circuit of the dialysis access including arteriovenous (AV) fistula and synthetic AV graft.

Participants will be treated with Solaris DE. Researchers will compare the treatment with investigational product to Percutaneous Transluminal Angioplasty (PTA) alone within the AV fistula cohort in order to demonstrate superiority of Solaris DE.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, randomized (1:1), controlled, multicenter study to investigate the safety and efficacy of the Solaris DE in the treatment of hemodialysis patients with stenosis or occlusion of the venous outflow circuit. The study population includes three cohorts:

  • AVF cohort: subjects presenting an arteriovenous fistula (AVF) stenosis or occlusion of the peripheral venous outflow circuit, including the cephalic arch, will be randomized 1:1 between treatment with the test device (Solaris DE) or standard treatment by Percutaneous Transluminal Angioplasty (PTA) alone;
  • AVG cohort: subjects with an arteriovenous graft (AVG) presenting stenosis or occlusion at the graft vein anastomosis or juxta-anastomosis or at the segment of the prosthesis exit circuit, will be treated with the test device (Solaris DE) only.
  • AVF/ AVG cohort: subjects with AVF/AVG for hemodialysis who have stenosis or occlusion of the periferic venous outflow circuit (including the cephalic arch and anastomosis of the graft vein or juxta-anastomosis) will be treated with Solaris DE (200).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Brasilien
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 40323-010
        • Rekruttering
        • Hospital Ana Nery
        • Ledende efterforsker:
          • Leonardo Cortizo, MD
        • Kontakt:
          • Leonardo Cortizo, MD
    • Federal District
      • Brasília, Federal District, Brasilien, 70390-150
        • Rekruttering
        • Afya Hospital Dia LTDA
        • Ledende efterforsker:
          • Thiago Barroso, MD
        • Kontakt:
          • Thiago A Barroso, MD
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30130-100
        • Rekruttering
        • Hospital das Clínicas da UFMG/EBSERH
        • Kontakt:
          • Guilherme Castro, MD
        • Ledende efterforsker:
          • Guilherme Castro, MD
    • Pernambuco
      • Recife, Pernambuco, Brasilien, 52010-160
        • Rekruttering
        • Real Hospital Português de Beneficência em Pernambuco
        • Ledende efterforsker:
          • Douglas Cavalcanti, MD
        • Kontakt:
          • Douglas Cavacanti, MD
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasilien, 20551030
        • Rekruttering
        • Hospital Universitário Pedro Ernesto - UERJ
        • Kontakt:
          • Leonardo O Harduin, MD
        • Ledende efterforsker:
          • Leonardo O Harduin, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female, aged ≥ 18 years on the date of inclusion.
  2. Has a mature AVF or AVG in the arm that was created ≥ 30 days before the initial procedure and is in use for dialysis therapy.
  3. Subject has clinical and/or hemodynamic evidence of a venous flow obstruction or AV fistula or graft dysfunction.
  4. Provides written informed consent prior to any study-specific procedures.
  5. Is willing to submit to all follow-up evaluations accordingly with the specified schedule over 24 months.

Angiographic Inclusion Criteria:

  1. The target lesion is localized:

    1. On an arm (including the cephalic arch) in an individual with AVF, and not on the cannulation segment (needling zone), OR
    2. On anastomosis or juxta-anastomosis in an individual with VAS. The juxta-anastomosis is defined as a location such that the stent graft crosses the venous anastomosis.

  2. The target lesion involves a de novo stenotic lesion or restenosis.

  3. The target lesion is ≥ 5 cm from the arterial anastomosis.

  4. The target lesion originates ≥ 3 cm of the cannulation segment (needling zone).

  5. The target lesion has ≥ 50% stenosis by the operator's visual estimate.

  6. The diameter of the distal reference vessel/graft is between 4.0 mm and 9.0 mm.

  7. The target lesion should be ≤ 8 cm in total length by the operator's visual estimate.

  8. Single or multiple target lesions may be covered by a single or two overlapping stents, provided that they are treated as a single lesion with a maximum length of 8 cm.

  9. There was a successful predilation of the target lesion, defined as crossing the guidewire resulting in full expansion of the predilation balloon.

  10. It presents up to 1 (one) non-target lesion in the access circuit requiring intervention in the initial procedure. The non-target lesion must be at least 10 cm away from the target lesion. The non-target lesion can only be treated with standard PTA.

  11. The non-target lesion was successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).

  12. It does not have an endoprosthesis or has been in the access circuit for ≥ 30 days since placement and patent with ≤ 30% stenosis and is located ≥ 5 cm from the target lesion.

Exclusion Criteria:

  1. Pregnant, breastfeeding or intending to become pregnant in the next year.
  2. Presents with any planned major endovascular or surgical procedure (including in the access loop) within 30 days of the initial procedure.
  3. Planned surgical revision of the access site.
  4. Known or suspected hemodialysis access site infection, systemic infection, and/or septicemia.
  5. Patients on immunosuppressive therapy.
  6. Known active coagulopathy or bleeding diathesis.
  7. Known hypersensitivity to nickel titanium alloy, contrast or Sirolimus.
  8. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapies.
  9. Known allergy to contrast agents or medications administered to perform endovascular intervention that cannot be adequately premedicated.
  10. Life expectancy less than 12 months.
  11. It is anticipated that the individual's hemodialysis access will be abandoned within 6 months.
  12. The patient is participating in another research study involving an investigational product (pharmaceutical, biologic, or medical device).
  13. The patient has a permanent central venous catheter (CVC) for dialysis access, except when the use is temporary, as a bridge to treatment through the access circuit and there is a plan for removal after a successful dialysis session after the initial procedure.

Angiographic Exclusion Criteria:

  1. Has a stent or stent graft located at any point in the AV access circuit that is not patent (> 30% stenosis) or implanted < 30 days.

  2. The target lesion is < 5 cm from the arterial anastomosis.

  3. It was not possible to perform predilation of the target lesion to be treated with Solaris DE.

  4. There was dissection/rupture of the treated vessel during the initial treatment that could not be controlled.

  5. There is evidence of an aneurysm, pseudoaneurysm, or acute thrombus in the target lesion. (Note: The aneurysm or pseudoaneurysm present at the access but outside the target lesion can be treated during the initial procedure. Patients with acute thrombus can only be included after 15 days of thrombus treatment).

  6. The target lesion is, and/or Solaris DE would be placed anywhere:

    1. In the elbow region and joint
    2. In a region that causes bending of the stent graft or bone protrusion over it
    3. In the cannulation segment (needling zone)
    4. Within any part of a pre-existing stent/stent graft (except for the arteriovenous graft of the access)
    5. Lower End
    6. Non-synthetic graft
    7. Central thoracic veins located proximally to the arch of the cephalic vein.

  7. The subject has more than one (1) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AVF Treatment

Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation.
Enhed: Solaris DE

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
Sham-komparator: AVF Control

Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) alone.
Enhed: PTA

Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.
Eksperimentel: AVG Treatment

Participants on dialysis via AV graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation.
Enhed: Solaris DE

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
Eksperimentel: AVF/ AVG Treatment

Participants on dialysis via AV fistula or graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE (200) implantation.
Enhed: Solaris DE (200)

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Events
Tidsramme: 30 days

Percentage of participants without any safety events affecting the access or venous outflow circuit and resulting in new intervention, hospitalization or death (not including stenosis or thrombosis).
30 days
Target Lesion Primary Patency (TLPP)
Tidsramme: 6 months

Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target Lesion Primary Patency (TLPP)
Tidsramme: 12 and 24 months

Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis.
12 and 24 months
Assisted Target Lesion Primary Patency (aTLPP)
Tidsramme: 1, 6, 12 and 24 months

Percentage of participants without uncorrectable occlusion of the target lesion since the procedure.
1, 6, 12 and 24 months
Access Circuit Primary Patency (ACPP)
Tidsramme: 1, 6, 12 and 24 months

Percentage of participants without any new venous outflow circuit intervention, thrombosis or access abandonment since the procedure.
1, 6, 12 and 24 months
Cumulative Patency (CP)
Tidsramme: 1, 6, 12 and 24 months

Percentage of participants without the access circuit abandonment since the procedure.
1, 6, 12 and 24 months
Procedure and device-related complications
Tidsramme: 1, 6, 12 and 24 months

Complication rates related to the procedure and device involving the access circuit.
1, 6, 12 and 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Scitech Produtos Medicos SA

Efterforskere

  • Ledende efterforsker: Leonardo C Almeida, MD, Hospital Ana Nery
  • Ledende efterforsker: Thiago A Almeida, MD, Afya Hospital Dia LTDA
  • Ledende efterforsker: Douglas E T Cavalcanti, MD, Real Hospital Português de Beneficência em Pernambuco
  • Ledende efterforsker: Guilherme C Santos, MD, Hospital das Clínicas da UFMG/EBSERH
  • Ledende efterforsker: Leonardo O Harduin, PhD, Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. august 2024

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

30. april 2029

Datoer for studieregistrering

Først indsendt

17. oktober 2023

Først indsendt, der opfyldte QC-kriterier

17. oktober 2023

Først opslået (Faktiske)

23. oktober 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SCI-SD-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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