Thrombectomy for pulmonary embolism in moderately to severely ill patients
Official title: Prospective Observational Study to Evaluate the Use of Computer-Aided Vacuum Thrombectomy Within the Context of Intermediate and High-Risk Pulmonary Embolism
Run by University Hospital Plymouth NHS Trust · NCT07650435 · Data updated 2026-11-12
This registry tests how well catheter-based thrombectomy works for patients with acute pulmonary embolism who are at intermediate or high risk.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | University Hospital Plymouth NHS Trust Academic / other |
| Locations | 1 site (Plymouth) |
| Status | Recruiting |
| Started | May 11, 2026 |
| Main results expected | December 11, 2029 |
| Study ends | December 11, 2029 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07650435 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with acute intermediate- or high-risk pulmonary embolism, confirmed by CT, within 14 days of symptoms, and evidence of right heart strain.
✕Probably not a fit
Patients with low-risk PE or without right heart strain may not experience substantial benefit from thrombectomy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects data on patients with acute pulmonary embolism who are treated with catheter-directed thrombectomy or related procedures. It aims to characterize safety, effectiveness, and patient-reported outcomes, particularly in those with intermediate or high-risk PE. The study records clinical features, treatments received, and longer-term outcomes to help inform clinical decisions and guideline recommendations. Participation requires confirmed PE, symptoms within 14 days, and informed consent, with data gathered from the University Hospital Plymouth NHS Trust. The goal is to build an evidence base to support or refine use of percutaneous thrombectomy in sicker patients.
Why it matters
Potential benefit: If successful, the registry could clarify who benefits most from thrombectomy and help guide safer, more effective use of the procedure.
How similar studies have gone: Prior small studies suggest feasibility and safety, but larger, more definitive data are needed in moderately to severely ill patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Plymouth NHS Trust
Plymouth, United Kingdom Recruiting
Study contacts
- Study coordinator: Paul Jenkins
- Email: plh-tr.tipe@nhs.net
- Phone: 01752438000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.