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Thrombectomy in Pulmonary Embolism (TiPE)

22 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

2000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Storbritannien
      • Plymouth, Storbritannien
        • Rekrytering
        • University Hospital Plymouth NHS Trust
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
CAVT thrombectomy
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
PE with evidence of right heart strain

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
LV/RV ratio
Tidsram: 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
Tidsram: 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).

Samarbetspartners och utredare

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Sponsor

University Hospital Plymouth NHS Trust

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 maj 2026

Primärt slutförande (Beräknad)

11 december 2029

Avslutad studie (Beräknad)

11 december 2029

Studieregistreringsdatum

Först inskickad

10 juni 2026

Först inskickad som uppfyllde QC-kriterierna

10 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 24RAD100
  • 362530 (Annan identifierare: IRAS)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

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