Thrombectomy in PE (TIPE)

June 10, 2026 updated by: University Hospital Plymouth NHS Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Plymouth, United Kingdom
        • Recruiting
        • University Hospital Plymouth NHS Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV/RV ratio
Time Frame: 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
Time Frame: 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Plymouth NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

December 11, 2029

Study Completion (Estimated)

December 11, 2029

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24RAD100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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