Thrombectomy in Pulmonary Embolism (TiPE)
22 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
2000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Paul Jenkins
- Numéro de téléphone: 01752438000
- E-mail: plh-tr.tipe@nhs.net
Sauvegarde des contacts de l'étude
- Nom: Thomas Mindos Trial Manager
- Numéro de téléphone: 01752438000
- E-mail: plh-tr.tipe@nhs.net
Lieux d'étude
-
-
-
Plymouth, Royaume-Uni
- Recrutement
- University Hospital Plymouth NHS Trust
-
Contact:
- Paul Jenkins BMBS, Bsc
- Numéro de téléphone: 01752438000
- E-mail: plh-tr.tipe@nhs.net
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients with PE <14 days and evidence of right heart strain
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
CAVT thrombectomy
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
|
|
PE with evidence of right heart strain
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
LV/RV ratio
Délai: 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
Délai: 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).
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 mai 2026
Achèvement primaire (Estimé)
11 décembre 2029
Achèvement de l'étude (Estimé)
11 décembre 2029
Dates d'inscription aux études
Première soumission
10 juin 2026
Première soumission répondant aux critères de contrôle qualité
10 juin 2026
Première publication (Réel)
16 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24RAD100
- 362530 (Autre identifiant: IRAS)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .