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[Teste do dispositivo que não é aprovado ou liberado pelo FDA dos EUA] (ARCH)

25 de agosto de 2026 atualizado por: C. R. Bard
The objective of the study is to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension from cirrhosis. This includes recurrent or refractory ascites, hepatic hydrothorax, and/or variceal bleeding (esophageal and/or gastric).

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

This is a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the BD Liverty™ TIPS Stent Graft for the treatment of the complications of portal hypertension. Safety and effectiveness measures for subjects receiving the BD Liverty™ TIPS Stent Graft will be compared to a Performance Goal (PG) derived from published literature.

Tipo de estudo

Intervencional

Inscrição (Real)

177

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 13353
        • Charité-Universitätsmedizin Berlin
      • Bonn, Alemanha, 53127
        • Universitatsklinikum Bonn
      • Dresden, Alemanha, 01307
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Frankfurt, Alemanha, 60590
        • University Hospital Frankfurt
      • Hanover, Alemanha, 30625
        • Medizinische Hochschule Hannover
      • Münster, Alemanha, 48149
        • Westfälische Wilhelms-Universität
  • Estados Unidos
    • California
      • Palo Alto, California, Estados Unidos, 94305
        • Stanford University
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20007
        • Georgetown University
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Trustees of Indiana University ("IU")/ Indiana University Health, Inc.
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • University of Kansas Medical Center Research Institute, Inc.
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Israel Deaconess Medical Center, Inc.
      • Boston, Massachusetts, Estados Unidos, 02114
        • The General Hospital Corporation d/b/a Massachusetts General Hospital
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University - Mallinckrodt Institute of Radiology
    • New Jersey
      • Newark, New Jersey, Estados Unidos, 07103
        • Rutgers, The State University of New Jersey
    • New York
      • New York, New York, Estados Unidos, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Estados Unidos, 10032
        • The Trustees of Columbia University in the City of New York
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Charlotte Radiology
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19125
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • The University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • University of Virginia
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin / Froedtert Hospital
  • França
      • Chambray-lès-Tours, França, 37170
        • Centre Hospitalier Régional Universitaire de Tours
      • Dijon, França, 21079
        • CHU Dijon Bourgogne
      • Lyon, França, 69002
        • Hospices Civils de Lyon

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. The subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to the conduct of any study-specific procedures including any procedure required to determine subject eligibility (apart from those conducted as part of the subject's routine clinical management).
  2. The subject must be ≥18 years of age with a life expectancy of ≥12 months to allow for adequate completion of study procedures and collection of data.
  3. The subject must be willing and able to comply with protocol requirements, including all study visits and procedures.

  4. The subject must have a diagnosis of portal hypertension from cirrhosis with at least one of the following indications for de novo TIPS creation including:

    1. Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy)
    2. Hepatic Hydrothorax
    3. Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding
    4. Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding
  5. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤18 or Child-Pugh Score of ≤12.
  6. The subject must have a platelet count of ≥50,000/microliter (with correction, if needed), as determined by the most recent pre-treatment laboratory tests performed within 7 days prior to treatment (Index Procedure).

Note: If multiple lab tests are performed within 7 days prior to the date of Index Procedure, the most recent results must demonstrate eligibility.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

  1. The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum).
  2. The subject has undergone prior transcatheter procedures for the treatment of complications from portal hypertension (e.g., TIPS, surgical shunt creation, peritoneovenous shunt, retrograde transvenous obliteration (-RTO)). Note: Subjects with variceal bleeding that have undergone -RTO at least 8 weeks prior to the planned Index Procedure may be enrolled.
  3. The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC).
  4. The subject is hemodynamically unstable with uncontrolled bleeding.
  5. The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled.
  6. The subject has undergone prior liver transplant or is a current transplant candidate that is likely to undergo liver transplant within 6 months of enrollment.
  7. The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment.
  8. The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy.

  9. The subject has any of the following medical conditions contraindicated to placement of TIPS:

    1. Congestive Heart Failure or Pulmonary Edema
    2. Severe Tricuspid Regurgitation
    3. Elevated Right or Left Heart Pressures
    4. Polycystic Liver Disease
    5. Moderate or Severe Pulmonary Hypertension or Severe Hepatopulmonary Syndrome
    6. Uncontrolled Systemic Infection or Sepsis
    7. Unrelieved Biliary Obstruction
    8. Acute Kidney Injury, Renal Failure, or Dialysis
    9. Uncontrolled Blood Coagulation/Bleeding Disorder
  10. The subject has a known allergy, intolerance, or condition (e.g., allergy to contrast media/narcotics/sedatives, bleeding diathesis, or severe peripheral arterial disease) that cannot be adequately pre-treated and would preclude angiography or selective catheterization.
  11. The subject has a known allergy or hypersensitivity to any of the device materials including nickel-titanium (nitinol) or tantalum.
  12. The subject is taking a medication or has another medical condition, which, in the opinion of the Investigator, would preclude safe treatment with the BD Liverty™ TIPS Stent Graft, may cause the subject to be non-compliant with the protocol, or may confound the data interpretation.
  13. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Subjects
Subjects that are treated with the BD Liverty™ TIPS Stent Graft
Dispositivo: BD Liverty™ TIPS Stent Graft
Treatment of portal hypertension complications with placement of the BD Liverty™ TIPS Stent Graft after creation of a Transjugular Intrahepatic Portosystemic Shunt.
Outros nomes:
  • PONTAS

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Freedom from Major Complications through 30 days post-Index Procedure
Prazo: 30 days

The primary safety endpoint is Freedom from Major Complications through 30 days post-Index Procedure.

Major complications are defined as:

The following Adverse Events (if determined to be related to the device and/or procedure and to meet the definition of a Serious Adverse Event (SAE)):

  • Accelerated Liver Failure
  • Biliary Peritonitis
  • Caval Occlusion
  • Death
  • Hemobilia
  • Hemoperitoneum
  • Hepatic Artery Injury
  • Hepatic Infarction
  • Radiation Skin Burn
  • Renal Failure
  • Severe Hepatic Encephalopathy
  • Vascular Perforation (resulting from stent graft malposition due to excessive extension of the stent graft into the inferior vena cava or the right atrium)

The following Device Deficiencies, if having the potential to or if confirmed to have led to a Serious Adverse Event (SAE):

o Stent Migration (within the portal or systemic venous circulations resulting from stent graft malposition)
30 days
Freedom from Shunt Dysfunction through 6 months post-Treatment Completion
Prazo: 6 months
The primary effectiveness endpoint is Freedom from Shunt Dysfunction through 6-months post-Treatment Completion. Shunt Dysfunction is defined as the proportion of subjects free from both a >50% reduction of the lumen of the stent (confirmed by direct shunt venography for subjects with suspected shunt dysfunction) and a PSG greater than the PSG achieved post-TIPS Index Procedure. Treatment Completion is defined as the latter to occur of (i) completion of the Index Procedure and (ii) if performed, the Tailored Expansion Procedure (TEP).
6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Technical Success
Prazo: Index Procedure
Technical Success, defined as the successful creation of a BD Liverty™ TIPS Stent Graft lined shunt between the hepatic vein and a branch of the portal vein, as assessed by the Investigator during the Index Procedure.
Index Procedure
Hemodynamic Success
Prazo: Index Procedure
Hemodynamic Success, defined as the successful post-TIPS reduction of the portosystemic gradient (PSG) to an Investigator-determined target of ≤12 mmHg or by ≥50% from the baseline PSG, as assessed by the Investigator during the Index Procedure.
Index Procedure
Clinical Success for subjects with Recurrent or Refractory Ascites
Prazo: 3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with recurrent or refractory ascites through 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from large volume paracentesis (LVP) of >5L occurring >6 weeks post-Treatment Completion.
3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with Hepatic Hydrothorax
Prazo: 3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with hepatic hydrothorax through 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from thoracentesis of >1L occurring >6 weeks post-Treatment Completion.
3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with Esophagogastric Variceal Re-Bleeding
Prazo: 3, 6, 12, 18, and 24 months post-Treatment Completion
Clinical Success for subjects with esophagogastric variceal bleeding through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion, defined as freedom from endoscopically-confirmed esophagogastric variceal re-bleeding.
3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Re-Intervention
Prazo: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Re-Intervention through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion.
1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria
Prazo: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Hepatic Encephalopathy of Grade ≥3 per West Haven Criteria through 1, 3, 6, 12, 18, and 24 months post-Treatment Completion.
1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Liver Transplant-Free Survival
Prazo: Through 24 months
Liver Transplant-Free Survival post-Index Procedure, defined as the proportion of subjects with freedom from death from any cause and from liver transplantation.
Through 24 months
Overall Survival
Prazo: Through 24 months
Overall Survival post-Index Procedure, defined as the proportion of subjects with freedom from death from any cause.
Through 24 months
Health-Related Quality of Life (HRQoL) Questionnaire
Prazo: 1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Health-Related Quality of Life (HRQoL) at Screening and at 1, 3, 6, 12, 18, and 24 months post-Treatment Completion, as measured by PROMIS-29 Profile v2.1.
1, 3, 6, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Dysfunction
Prazo: 1, 3, 12, 18, and 24 months post-Treatment Completion
Freedom from Shunt Dysfunction through 1, 3, 12, 18, and 24 months post-Treatment Completion. Shunt Dysfunction is defined as the proportion of subjects free from both a >50% reduction of the lumen of the stent (confirmed by direct shunt venography for subjects with suspected shunt dysfunction) and a PSG greater than the PSG achieved post-TIPS Index Procedure.
1, 3, 12, 18, and 24 months post-Treatment Completion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

C. R. Bard

Investigadores

  • Investigador principal: Ziv Haskal, M.D., University of Virginia

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de agosto de 2023

Conclusão Primária (Real)

23 de junho de 2025

Conclusão do estudo (Estimado)

11 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de janeiro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de janeiro de 2023

Primeira postagem (Real)

3 de fevereiro de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de agosto de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BDPI-20-004

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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