RecruitingNCT07650435

Thrombectomy in PE

PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE THE USE OF COMPUTER AIDED VACCUM THROMBECTOMY WITHIN THE CONTEXT OF INTERMEDIATE AND HIGH-RISK PE.

Sponsor

University Hospital Plymouth NHS Trust

Enrollment

2,000 participants

Start Date

May 11, 2026

Study Type

OBSERVATIONAL

Conditions

Pulmonary Embolism and Thrombosis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria1

\. 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

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