The Solaris DE Sirolimus-Eluting Covered Stent for the Treatment of AV Access Stenosis or Occlusion (DEScover)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Marco A Costa
- Número de telefone: +55 62 3625-3751
- E-mail: marco.costa@scitechmed.com
Estude backup de contato
- Nome: Ana Paula B A Pellaquim
- Número de telefone: +55 62 3625-3751
- E-mail: aalmeida@scitechmed.com
Locais de estudo
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40323-010
- Recrutamento
- Hospital Ana Nery
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Investigador principal:
- Leonardo Cortizo, MD
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Contato:
- Leonardo Cortizo, MD
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Federal District
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Brasília, Federal District, Brasil, 70390-150
- Recrutamento
- Afya Hospital Dia LTDA
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Investigador principal:
- Thiago Barroso, MD
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Contato:
- Thiago A Barroso, MD
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30130-100
- Recrutamento
- Hospital das Clínicas da UFMG/EBSERH
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Contato:
- Guilherme Castro, MD
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Investigador principal:
- Guilherme Castro, MD
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Pernambuco
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Recife, Pernambuco, Brasil, 52010-160
- Recrutamento
- Real Hospital Português de Beneficência em Pernambuco
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Investigador principal:
- Douglas Cavalcanti, MD
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Contato:
- Douglas Cavacanti, MD
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Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro, Brasil, 20551030
- Recrutamento
- Hospital Universitário Pedro Ernesto - UERJ
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Contato:
- Leonardo O Harduin, MD
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Investigador principal:
- Leonardo O Harduin, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Male or female, aged ≥ 18 years on the date of inclusion.
- 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.
- Subject has clinical and/or hemodynamic evidence of a venous flow obstruction or AV fistula or graft dysfunction.
- Provides written informed consent prior to any study-specific procedures.
- Is willing to submit to all follow-up evaluations accordingly with the specified schedule over 24 months.
Angiographic Inclusion Criteria:
-
The target lesion is localized:
- On an arm (including the cephalic arch) in an individual with AVF, and not on the cannulation segment (needling zone), OR
- 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.
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The target lesion involves a de novo stenotic lesion or restenosis.
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The target lesion is ≥ 5 cm from the arterial anastomosis.
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The target lesion originates ≥ 3 cm of the cannulation segment (needling zone).
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The target lesion has ≥ 50% stenosis by the operator's visual estimate.
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The diameter of the distal reference vessel/graft is between 4.0 mm and 9.0 mm.
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The target lesion should be ≤ 8 cm in total length by the operator's visual estimate.
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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.
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There was a successful predilation of the target lesion, defined as crossing the guidewire resulting in full expansion of the predilation balloon.
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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.
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The non-target lesion was successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).
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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:
- Pregnant, breastfeeding or intending to become pregnant in the next year.
- Presents with any planned major endovascular or surgical procedure (including in the access loop) within 30 days of the initial procedure.
- Planned surgical revision of the access site.
- Known or suspected hemodialysis access site infection, systemic infection, and/or septicemia.
- Patients on immunosuppressive therapy.
- Known active coagulopathy or bleeding diathesis.
- Known hypersensitivity to nickel titanium alloy, contrast or Sirolimus.
- Contraindication to antiplatelet, anticoagulant, or thrombolytic therapies.
- Known allergy to contrast agents or medications administered to perform endovascular intervention that cannot be adequately premedicated.
- Life expectancy less than 12 months.
- It is anticipated that the individual's hemodialysis access will be abandoned within 6 months.
- The patient is participating in another research study involving an investigational product (pharmaceutical, biologic, or medical device).
- 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:
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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.
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The target lesion is < 5 cm from the arterial anastomosis.
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It was not possible to perform predilation of the target lesion to be treated with Solaris DE.
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There was dissection/rupture of the treated vessel during the initial treatment that could not be controlled.
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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).
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The target lesion is, and/or Solaris DE would be placed anywhere:
- In the elbow region and joint
- In a region that causes bending of the stent graft or bone protrusion over it
- In the cannulation segment (needling zone)
- Within any part of a pre-existing stent/stent graft (except for the arteriovenous graft of the access)
- Lower End
- Non-synthetic graft
- Central thoracic veins located proximally to the arch of the cephalic vein.
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The subject has more than one (1) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: AVF Treatment
Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. |
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel. |
|
Comparador Falso: AVF Control
Participants on dialysis via AV fistula will be treated with percutaneous transluminal angioplasty (PTA) alone. |
Percutaneous Transluminal Angioplasty (PTA) in the treated vessel alone. |
|
Experimental: AVG Treatment
Participants on dialysis via AV graft will be treated with percutaneous transluminal angioplasty (PTA) followed by Solaris DE implantation. |
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (75μg of Sirolimus) implantation in the treated vessel. |
|
Experimental: 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. |
Percutaneous Transluminal Angioplasty (PTA) followed by Solaris DE (200μg of Sirolimus) implantation in the treated vessel. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety Events
Prazo: 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)
Prazo: 6 months
|
Percentage of participants without restenosis or clinically indicated target lesion revascularization or thrombosis. |
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Target Lesion Primary Patency (TLPP)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 1, 6, 12 and 24 months
|
Complication rates related to the procedure and device involving the access circuit. |
1, 6, 12 and 24 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Leonardo C Almeida, MD, Hospital Ana Nery
- Investigador principal: Thiago A Almeida, MD, Afya Hospital Dia LTDA
- Investigador principal: Douglas E T Cavalcanti, MD, Real Hospital Português de Beneficência em Pernambuco
- Investigador principal: Guilherme C Santos, MD, Hospital das Clínicas da UFMG/EBSERH
- Investigador principal: Leonardo O Harduin, PhD, Hospital Universitário Pedro Ernesto - Universidade do Estado do Rio de Janeiro (HUPE-UERJ)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Processos Patológicos
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doença crônica
- Atributos da doença
- Insuficiência renal
- Insuficiência Renal Crônica
- Condições Patológicas, Sinais e Sintomas
- Insuficiência Renal Crônica
Outros números de identificação do estudo
- SCI-SD-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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