Thrombectomy in Pulmonary Embolism (TiPE)
22 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
2000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Paul Jenkins
- Número de teléfono: 01752438000
- Correo electrónico: plh-tr.tipe@nhs.net
Copia de seguridad de contactos de estudio
- Nombre: Thomas Mindos Trial Manager
- Número de teléfono: 01752438000
- Correo electrónico: plh-tr.tipe@nhs.net
Ubicaciones de estudio
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Plymouth, Reino Unido
- Reclutamiento
- University Hospital Plymouth NHS Trust
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Contacto:
- Paul Jenkins BMBS, Bsc
- Número de teléfono: 01752438000
- Correo electrónico: plh-tr.tipe@nhs.net
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with PE <14 days and evidence of right heart strain
Descripción
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:
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- Patients who present with CT confirmed PE
- Defined as intermediate or high-risk PE (according to ESC guidelines1)
- Date of CT imaging from within a two-year period
- Patient is ≥ 18 years of age
- Informed consent obtained
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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CAVT thrombectomy
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
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PE with evidence of right heart strain
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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LV/RV ratio
Periodo de tiempo: 48 (+ 48 /- 24) hours post procedure.
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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.
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48 (+ 48 /- 24) hours post procedure.
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Morbidity and mortality
Periodo de tiempo: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
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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).
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within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Konstantinides SV, Barco S, Lankeit M, Meyer G. Management of Pulmonary Embolism: An Update. J Am Coll Cardiol. 2016 Mar 1;67(8):976-990. doi: 10.1016/j.jacc.2015.11.061.
- Sista AK, Miller LE, Kahn SR, Kline JA. Persistent right ventricular dysfunction, functional capacity limitation, exercise intolerance, and quality of life impairment following pulmonary embolism: Systematic review with meta-analysis. Vasc Med. 2017 Feb;22(1):37-43. doi: 10.1177/1358863X16670250. Epub 2016 Oct 5.
- 11. National institute of Clinical Excellence. Pulmonary embolism: what are the risk factors. NICE guidelines. https://cks.nice.org.uk/topics/pulmonary-embolism/background-information/risk-factors/
- Noble S, Lewis R, Whithers J, Lewis S, Bennett P. Long-term psychological consequences of symptomatic pulmonary embolism: a qualitative study. BMJ Open. 2014 Apr 2;4(4):e004561. doi: 10.1136/bmjopen-2013-004561.
- Danielsbacka JS, Rostberg L, Olsen MF, Mannerkorpi K. "Whole life changed" - Experiences of how symptoms derived from acute pulmonary embolism affects life. A qualitative interview study. Thromb Res. 2021 Sep;205:56-62. doi: 10.1016/j.thromres.2021.07.004. Epub 2021 Jul 5.
- 8. Perkowski, Paul et al Computer-aided Mechanical Aspiration Thrombectomy with the Indigo Lightning 12 Aspiration System for the Treatment of Acute Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study.Journal of Vascular Surgery, Volume 77, Issue 4, 52S - 53S
- Moriarty JM, Dohad SY, Schiro BJ, Tamaddon H, Heithaus RE, Iliadis EA, Dexter DJ 2nd, Shavelle DM, Leal SRN, Attallah AS, West FM, Keeling WB, Sharp ASP, Weinberg I. Clinical, Functional, and Quality-of-Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study. J Vasc Interv Radiol. 2024 Aug;35(8):1154-1165.e6. doi: 10.1016/j.jvir.2024.04.028. Epub 2024 May 9.
- Mathews SJ. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration. Tex Heart Inst J. 2021 Nov 1;48(5):e217571. doi: 10.14503/THIJ-21-7571. No abstract available.
- Gotzinger F, Lauder L, Sharp ASP, Lang IM, Rosenkranz S, Konstantinides S, Edelman ER, Bohm M, Jaber W, Mahfoud F. Interventional therapies for pulmonary embolism. Nat Rev Cardiol. 2023 Oct;20(10):670-684. doi: 10.1038/s41569-023-00876-0. Epub 2023 May 12.
- Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019 Nov 12;140(20):e774-e801. doi: 10.1161/CIR.0000000000000707. Epub 2019 Oct 4.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de mayo de 2026
Finalización primaria (Estimado)
11 de diciembre de 2029
Finalización del estudio (Estimado)
11 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
10 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 24RAD100
- 362530 (Otro identificador: IRAS)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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:
- The viability and suitability of the request
- Appropriate steps have been taken to minimise the risk of identifying participants
- Data security policies and procedures of recipient organisation (including country if abroad) and other regulatory requirements are applicable
- 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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