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Thrombectomy in Pulmonary Embolism (TiPE)

22 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

2000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
CAVT thrombectomy
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
PE with evidence of right heart strain

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
LV/RV ratio
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital Plymouth NHS Trust

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 mei 2026

Primaire voltooiing (Geschat)

11 december 2029

Studie voltooiing (Geschat)

11 december 2029

Studieregistratiedata

Eerst ingediend

10 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 24RAD100
  • 362530 (Andere identificatie: IRAS)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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