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The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion

NCT06096142 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-17

No results posted yet for this study

Summary

The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris DE Endoprosthesis 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 Endoprosthesis. 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.

Conditions

  • Venous Stenosis
  • Venous Occlusion
  • Chronic Renal Failure

Interventions

DEVICE

Solaris DE

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

DEVICE

PTA

Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone.

Sponsors & Collaborators

  • Scitech Produtos Medicos SA

    lead INDUSTRY

Principal Investigators

  • Leonardo O Harduin, MD · Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)

  • Leonardo C Almeida, MD · Hospital Ana Nery

  • Thiago A Almeida, MD · Afya Hospital Dia LTDA

  • Douglas E T Cavalcanti, MD · Real Hospital Português de Beneficência em Pernambuco

  • Guilherme C Santos, MD · Hospital das Clínicas da UFMG/EBSERH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2026-08-31
Completion
2028-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096142 on ClinicalTrials.gov