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Catheter-Directed Clot-Busting may offer safer option for dangerous blood clots in the lungs

NCT ID NCT05493163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether delivering a clot-dissolving drug directly into the lung arteries via a thin tube (catheter) can improve outcomes for people with a serious type of pulmonary embolism (a blood clot in the lung). Participants have intermediate-high risk clots, meaning they are at increased risk of complications but not in shock. Half receive the catheter treatment plus standard blood thinners, and half receive standard blood thinners alone. The study tracks deaths, clot recurrence, and heart or breathing collapse within the first week, along with longer-term recovery and quality of life.

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 thrombolysis (thrombolytic drug delivered locally via catheter)
What this could lead to
If successful, this approach could reduce deaths and complications from pulmonary embolism without the high bleeding risk seen with systemic clot-busting drugs.
What could go wrong
This is a Phase 4 trial, but the intervention still carries bleeding risks, and the benefit over standard care is not yet proven in a large study.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

558 people

The number who actually took part.

Started

Oct 2022

Finished

Mar 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 80 years

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 and not over 80 years. 2. Computed tomography angiography (CTA)-verified proximal\* PE AND symptom onset \< 14 days prior. 3. Intermediate-high risk PE with a SPESI score ≥ 1 AND RV dysfunction\*\* AND an elevated biomarker \*\*\* (hs-troponin or NT-proBNP) level. 4. Signed informed consent. Exclusion Criteria: 1. Active clinically significant bleeding. 2. Any haemorrhagic stroke OR a recent (\< 6 months) ischaemic stroke/transient ischaemic attack. 3. Recent (\< 3 months) cranial trauma OR another active intracranial/intraspinal process. 4. Major surgery within 7 days prior. 5. Active malignancy OR other severe illness with expected survival \< 2 years. 6. Haemoglobin level \< 80 g/L; international normalised ratio \> 2.0, platelet count ≤ 100 x 109; creatinine level \> 200 µmol/L. 7. Pregnant or breastfeeding, fertility without previous exclusion of gravidity. 8. Allergic to thrombolytics or heparin or low-molecular-weight heparin (LMWH), contrast allergy, a history of heparin-induced thrombocytopenia. 9. Floating thrombi in transit through a patent foramen ovale. 10. Participation in another clinical trial. * A perfusion defect in at least one main or one lobar pulmonary artery is evident on CTA. * RV/LV ratio ≥ 0.9 on transthoracic echocardiography or CTA. \*\*\* hs-troponin I (TnI) \> 53 ng/L (men) or \> 34 ng/L (women), hs-troponin T (hs cTnT) \> 14 ng/L; NT-proBNP level \> 600 pg/mL, BNP \> 100 pg/mL. SPESI - Simplified Pulmonary Embolism Severity Index.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University Hospital Kralovske Vinohrady

    Prague, Prague, 100 34, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.