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Thrombectomy in Pulmonary Embolism (TiPE)

22 de junho de 2026 atualizado por: University Hospital Plymouth NHS Trust

Prospective Observational Study to Evaluate the Use of Computer-Aided Vacuum Thrombectomy Within the Context of Intermediate and High-Risk Pulmonary Embolism

Pulmonary embolism is a blood clot on the lung, which can cause death or significant reduced quality of life. Sucking the clot out with a special tube (catheter) is a relatively new procedure that can be performed but doesn't have the data required to properly support its use in some patients. We know this procedure works in patients who have no other options and would almost certainly die without intervention. We currently don't know how well this procedure is tolerated, how well it works and what its complications are in patients who are moderately to severely unwell. The National Institute of Clinical Excellence (NICE), an advisory body, suggests more data is required to support its use in patients who are sick or very sick. This registry aims to support this growing evidence base to workout if the treatment is effective and the associated risks that come with using it. We are collecting data about this procedure and other treatments patients get offered to better inform clinicians and researchers.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

Acute intermediate-risk pulmonary embolism (PE) and high-risk PE can be life threatening. The incidence of PE is increasing , and patients who survive the acute presentation may experience significant morbidity including reduced exercise tolerance, and decreased quality of life (QoL). Often patients are treated with anticoagulation to stop the clot getting worse and encourage the body to slowly break up the clot. However in more severe cases thrombolysis medication can be given to actively break up the clot. Catheter directed thrombolysis can be used to target the lytic medication into the pulmonary arteries and reduced the systemic effects. Percutaneous thrombectomy is a newer treatment option that aspirates the clot, providing a faster and potentially lytic free solution to sick patients. Pulmonary artery thrombectomy (PAT) is a treatment option that is variably utilised and has unclear evidence base . The penumbra device uses a computer modulated vacuum aspiration system to both fatigue, breakup and aspirate the clot. This has been shown to be safe and effective in small cohorts. CAVT can prevent acute hemodynamic decompensation, alleviate acute PE-related symptoms, accelerate right ventricular recovery, and improve quality of life as measured by patient-reported outcomes (PROs). Despite existing literature addressing clinical outcomes with PE treatment, comprehensive data on PE-related morbidity, PROs and longer-term outcomes after mechanical thrombectomy are still lacking.

Tipo de estudo

Observacional

Inscrição (Estimado)

2000

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.

Contato de estudo

Estude backup de contato

  • Nome: Thomas Mindos Trial Manager
  • Número de telefone: 01752438000
  • E-mail: plh-tr.tipe@nhs.net

Locais de estudo

  • Reino Unido
      • Plymouth, Reino Unido
        • Recrutamento
        • University Hospital Plymouth NHS Trust
        • Contato:

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

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with PE <14 days and evidence of right heart strain

Descrição

Inclusion Criteria:

  • Clinical signs and symptoms consistent with acute pulmonary embolism with duration of 14 days or less
  • Patients who present with computed tomography confirmed pulmonary embolism
  • Defined as intermediate or high-risk pulmonary embolism (according to European Society of Cardiology guidelines)
  • Date of computed tomography imaging from within a two-year period
  • Patient is greater than or equal to 18 years of age
  • Informed consent obtained
  • Evidence of cardiac dysfunction (either biochemical or imaging features of right heart strain)

Exclusion Criteria:

  • Known serious, uncontrolled sensitivity to radiographic agents
  • Computed tomography not available to evaluate pulmonary embolism
  • Low-risk pulmonary embolism as defined by European Society of Cardiology guidelines
  • Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
  • Other medical, social, or psychological conditions that, in the opinion of the investigator, preclude the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Inclusion Criteria:

  1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
  2. Patients who present with CT confirmed PE
  3. Defined as intermediate or high-risk PE (according to ESC guidelines1)
  4. Date of CT imaging from within a two-year period
  5. Patient is ≥ 18 years of age
  6. Informed consent obtained
  7. Evidence of cardiac dysfunction (Either biochemical or imaging features of RHS)

Exclusion Criteria:

  • 1. Known serious, uncontrolled sensitivity to radiographic agents 2. CT not available to evaluate PE 3. Low Risk PE as defined by ESC guidelines1 4. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies 5. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

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

Coortes e Intervenções

Grupo / Coorte
CAVT thrombectomy
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
PE with evidence of right heart strain

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
LV/RV ratio
Prazo: 48 (+ 48 /- 24) hours post procedure.
1. To evaluate the effectiveness of PE CAVT as a treatment for intermediate and high-risk PE as measured by change pulmonary arterial pressure and in RV/LV (Right Ventricle to Left Ventricle diameter) ratio at 48 (+ 48 /- 24) hours post procedure.
48 (+ 48 /- 24) hours post procedure.
Morbidity and mortality
Prazo: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Ascertain the mortality and morbidity profile for CAVT within intermediate and high-risk PE, within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).

Colaboradores e Investigadores

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

Patrocinador

University Hospital Plymouth NHS Trust

Publicações e links úteis

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Publicações Gerais

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)

11 de maio de 2026

Conclusão Primária (Estimado)

11 de dezembro de 2029

Conclusão do estudo (Estimado)

11 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de junho de 2026

Primeira postagem (Real)

16 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de junho 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

  • 24RAD100
  • 362530 (Outro identificador: IRAS)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Requests for data sharing can be made after publication of the primary results paper. Requests should be made to the Chief Investigator in the first instance. Requesters will be asked to complete an application form detailing specific requirements, rationale, and proposed usage. The CI and study sponsor (including the sponsor's Research Governance Manager (or deputy), the Information Governance Team, Calidcott Guardian, IM&T Security Officer and the researcher funder, as appropriate) will review all requests.

Consideration will be given to:

  1. The viability and suitability of the request
  2. Appropriate steps have been taken to minimise the risk of identifying participants
  3. Data security policies and procedures of recipient organisation (including country if abroad) and other regulatory requirements are applicable
  4. The credentials of the requestor Where access to requested data is granted, requesters organisation must sign a data sharing agreement before they can access any data.

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

Não

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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