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Completed

NCT Number: NCT05456789

Catheter-interventional Treatment of Pulmonary Embolism

Recent evidence supports the use of catheter-interventional techniques for the treatment of intermediate-high-risk pulmonary embolism. While there is evidence supporting the use of catheter-thrombectomy and alternatively local fibrinolysis, less is known on the combination of both approaches.

The investigators aim to assess the effects of a combined interventional local fibrinolysis and catheter-thrombectomy and to compare them with conventional treatment in a cohort of patients with intermediate-high-risk pulmonary embolism.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, 04289, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed intermediate high-risk pulmonary embolism
  • age >= 18 years

Exclusion criteria

  • high-risk pulmonary embolism
  • contraindications for catheter-based treatment
  • known allergy to anticoagulant treatment or fibrinolytics
  • pregnancy
  • participation in other randomized trials
  • patients under legal supervision or guardianship

Treatment and study plan

combined catheter-thrombectomy and local fibrinolysis

Device

combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment

conventional treatment

Other

conventional treatment of pulmonary embolism

Primary outcomes

  1. RV-LV-Ratio

    Time frame: Day 1 after randomization

    Change in right to left ventricular diameter ratio

  2. clinical efficacy

    Time frame: Day 1 after randomization

    quotient of systolic systemic blood pressure over heart rate and respiratory rate

Secondary outcomes

  1. Mortality

    Time frame: 1 day, 30 days, 1 year after randomization

    difference in mortality between the treatment groups

  2. Right heart failure

    Time frame: 30 days and 1 year after randomization

    difference in new onset right heart failure between the groups

  3. pulmonary artery pressure

    Time frame: 1 day, 30 days and 1 year after randomization

    difference in estimated pulmonary artery pressure between the groups

  4. RV/LV-ratio

    Time frame: 30 days and 1 year after randomization

    difference in RV/LV-ratio

  5. TAPSE

    Time frame: 1 day, 30 days and 1 year after randomization

    difference in TAPSE as assessed by transthoracic echocardiogram

  6. difference in RA volume between the groups

    Time frame: 1 day, 30 days and 1 year after randomization

    RA volume between the groups

  7. Bleeding

    Time frame: 1 day, 30 days and 1 year after randomization

    difference in BARC bleeding events between the groups

  8. Troponin and NT-proBNP

    Time frame: 30 days and 1 year after randomization

    difference in high-sensitivity Troponin T and NT-proBNP between the groups

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Registry information

Official study title

A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism

Acronym: CATCH-PE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2022
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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