Catheter-Directed Clot-Busting may offer safer option for dangerous blood clots in the lungs
NCT ID NCT05493163
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 Hide 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
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Other studies related to the condition(s) this trial covers.
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