An observational study in Pulmonary Embolism and Thrombosis, sponsored by University Hospital Plymouth NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University Hospital Plymouth NHS Trust · Observational
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.
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.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 361 across 366 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with PE \<14 days and evidence of right heart strain
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PE with evidence of right heart strain and thrombectomy with 16Fr CAVT
PE with evidence of right heart strain
LV/RV ratio
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.
Time frame: 48 (+ 48 /- 24) hours post procedure.
Morbidity and mortality
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).
Time frame: within 48 (± 12) hours post procedure, 30 (± 7) days, 90 (± 14) days and at 6months (+/- 30 days).
Plan to share: Undecided — 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.
Started May 2026 (actual). Primary completion is estimated for Dec 2029, 43 months after the start.
Of 135 non-industry observational studies under Pulmonary Embolism, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 119. This study's planned 43 months is below that.
Counting every sponsor, half of 160 studies reached it within 47 months; a quarter within 21 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
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University Hospital Plymouth NHS Trust