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New study pits Clot-Removal devices against drugs for dangerous lung clots

NCT ID NCT06453876

Disease control Sponsor: Jesper Kjaergaard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This phase 3 trial will test three ways to treat intermediate high-risk pulmonary embolism (a serious blood clot in the lungs). The study compares two catheter-based procedures (mechanical clot removal or low-dose clot-busting drug) with standard blood-thinning heparin. About 210 adults with recent symptoms will be enrolled. The goal is to see which method reduces clot burden most effectively within 48-96 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heparin, Alteplase, and catheter-based devices (AlphaVAC, FlowTriever, EKOS)
What this could lead to
If successful, this trial could identify the best approach to quickly reduce blood clots in the lungs, potentially improving recovery and reducing complications for people with serious pulmonary embolism.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients. Bleeding risks exist with all treatments, and the study is relatively small (210 participants).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA 1. Age ≥ 18 years 2. Intermediate high-risk PE according to ESC criteria 3. Class II risk assessed by the Pulmonary Embolism Severity Index (1). 4. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography 5. 14 days of symptoms or less, with significant worsening of symptoms within 7 days EXCLUSION CRITERIA 1. Altered mental state (GCS \< 14) 2. No qualifying CT angiography performed (\> 24 hour since CT angiography) 3. Women of childbearing potential, unless negative HCG test is present. 4. Thrombolysis for PE within 14 days of randomization 5. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism) 6. Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed) 7. Comorbidity making 6 months survival unlikely. 8. Absolute contraindications for thrombolysis: 1. History of haemorrhagic stroke or stroke of unknown origin 2. Ischaemic stroke in previous 6 months 3. Central nervous system neoplasm 4. Major trauma, surgery, or head injury in previous 3 weeks 5. Bleeding diathesis - Active bleeding

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary embolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Copenhagen University Hospital Rigshospitalet

    RECRUITING

    Copenhagen, DK2100, Denmark

  • Odense University Hospital

    NOT_YET_RECRUITING

    Odense, 5000, Denmark

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