Authorised Therapeutic use (Phase IV) intermediate-high risk acute pulmonary embolism

Catheter-directed thrombolysis in intermediate-high risk acute pulmonary embolism

EU CTIS ID: 2024-516144-25-00

What this study is testing

To investigate clinical outcomes (combined endpoint, clinical composite of any of following – any death, PE recurrence, cardiorespiratory decompensation) in patients treated by CDT compared to standard anticoagulation therapy.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age > 18 years and  80 years.
  • Computed tomography angiography (CTA)-verified proximal PE AND symptom onset < 14 days prior.
  • Intermediate-high risk PE with a sPESI score ≥ 1 AND RV dysfunction AND an elevated biomarker (hs-troponin or NT-proBNP) level.
  • Signed informed consent

You likely can't join if

  • Active clinically significant bleeding.
  • Participation in another clinical trial.
  • Any haemorrhagic stroke OR a recent (< 6 months) ischaemic stroke/transient ischaemic attack.
  • Recent (< 3 months) cranial trauma OR another active intracranial/intraspinal process.
  • Major surgery within 7 days prior.
  • Active malignancy OR other severe illness with expected survival < 2 years.
See the full eligibility criteria
Who can join
  • Age > 18 years and  80 years.
  • Computed tomography angiography (CTA)-verified proximal PE AND symptom onset < 14 days prior.
  • Intermediate-high risk PE with a sPESI score ≥ 1 AND RV dysfunction AND an elevated biomarker (hs-troponin or NT-proBNP) level.
  • Signed informed consent
What rules you out
  • Active clinically significant bleeding.
  • Participation in another clinical trial.
  • Any haemorrhagic stroke OR a recent (< 6 months) ischaemic stroke/transient ischaemic attack.
  • Recent (< 3 months) cranial trauma OR another active intracranial/intraspinal process.
  • Major surgery within 7 days prior.
  • Active malignancy OR other severe illness with expected survival < 2 years.
  • Haemoglobin level < 80 g/L; international normalised ratio > 2.0, platelet count ≤ 100 x 109; creatinine level > 200 μmol/L.
  • Pregnant or breastfeeding, fertility without previous exclusion of gravidity.
  • Allergic to thrombolytics or heparin or low-molecular-weight heparin (LMWH), contrast allergy, a history of heparin-induced thrombocytopenia.
  • Floating thrombi in transit through a patent foramen ovale.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.