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New trial aims to stop deadly blood clots with quick catheter action

NCT ID NCT06672081

Disease control Sponsor: Leipzig Heart Science gGmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a catheter to break up or remove blood clots early, along with standard care, can save more lives in people with a massive pulmonary embolism. About 210 participants will be randomly assigned to receive either catheter treatment within 60 minutes plus usual care, or usual care alone. The goal is to see if the catheter approach reduces death, cardiac arrest, or persistent shock.

What this could mean

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

Active substance
catheter-directed treatment (aspiration thrombectomy, local fibrinolytic therapy, or ultrasound-assisted fibrinolysis)
What this could lead to
If successful, this approach could become a standard early intervention for high-risk pulmonary embolism, potentially reducing deaths and serious complications.
What could go wrong
This is a relatively small, early-stage trial (210 participants) and the procedure carries risks like bleeding or vessel damage. Results may not apply to all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

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

Started

Dec 2024

Expected to finish

Jun 2027

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. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines: a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP \<90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan 2. Age ≥18 years Exclusion Criteria: 1. Contraindications for catheter-based treatment 2. Contraindications to systemic fibrinolytic treatment or anticoagulation\* 1. Active, potentially life-threatening bleeding 2. Surgery within 24h before screening 3. Cranial or spinal surgery within 14d before screening 4. Stroke within 14d before screening 5. Intracranial tumor 6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator 3. Pregnancy * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.

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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 acute massive

How to take part

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

  1. The places running it

    18 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

  • Asklepios Klinik St. Georg

    RECRUITING

    Hamburg, 20099, Germany

  • Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie

    RECRUITING

    Ulm, 89081, Germany

  • HELIOS Klinikum Erfurt

    RECRUITING

    Erfurt, 99089, Germany

  • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

    RECRUITING

    Leipzig, 04289, Germany

  • Helios Kliniken Wuppertal

    RECRUITING

    Wuppertal, 42117, Germany

  • Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd

    RECRUITING

    Nuremberg, 90471, Germany

  • Oberlausitzklinikum Bautzen, Medizinische Klinik I

    RECRUITING

    Bautzen, 02625, Germany

  • Rems-Murr-Kliniken

    RECRUITING

    Winnenden, 71364, Germany

  • SLK-Kliniken Heilbronn

    RECRUITING

    Heilbronn, 74078, Germany

  • Schwarzwald-Baar-Klinikum

    RECRUITING

    Villingen-Schwenningen, 78052, Germany

  • Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie

    RECRUITING

    Frankfurt am Main, 60590, Germany

  • Universitätsklinikum Freiburg

    RECRUITING

    Bad Krozingen, 79189, Germany

  • Universitätsklinikum Halle

    RECRUITING

    Halle, 06120, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2

    RECRUITING

    Kaiserslautern, 67655, Germany

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