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

1 ottobre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

160

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AVF Treatment

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

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

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

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

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

Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel.
Sperimentale: 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.
Dispositivo: Solaris DE (200)

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety Events
Lasso di tempo: 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)
Lasso di tempo: 6 months

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Target Lesion Primary Patency (TLPP)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 1, 6, 12 and 24 months

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Scitech Produtos Medicos SA

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 agosto 2024

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

30 aprile 2029

Date di iscrizione allo studio

Primo inviato

17 ottobre 2023

Primo inviato che soddisfa i criteri di controllo qualità

17 ottobre 2023

Primo Inserito (Effettivo)

23 ottobre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SCI-SD-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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