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NCT Number: NCT06672081

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Freiburg, Bad Krozingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

  • Age ≥18 years

Exclusion criteria

  • Contraindications for catheter-based treatment
  • Contraindications to systemic fibrinolytic treatment or anticoagulation*
  • Active, potentially life-threatening bleeding
  • Surgery within 24h before screening
  • Cranial or spinal surgery within 14d before screening
  • Stroke within 14d before screening
  • Intracranial tumor
  • Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
  • Pregnancy
  • Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.

Treatment and study plan

Early Catheter-Interventional Treatment

Procedure

Patients will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these.Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.

Conventional Care

Drug

reperfusion treatment

Primary outcomes

  1. Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock

    Time frame: 7 days

    • mortality (all-cause) up to 7 days after randomization and
    • either one of the following
    • recurrent cardiac arrest or
    • persistent / recurrent shock (systolic BP <90 mmHg or vasopressors or ECMO required to achieve a systolic BP ≥90 mmHg, in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) 24 hours after randomization

Secondary outcomes

  1. All-cause mortality

    Time frame: 7 days

    All-cause mortality at day 7 after randomization

  2. PE-related mortality

    Time frame: 7 days

    PE-related mortality at day 7 after randomization

  3. Mortality (all-cause)

    Time frame: 30 days

    Mortality (all-cause) at day 30 after randomization

  4. Bail out therapy

    Time frame: 7 days

    Bail out therapy at day 7 after randomization

  5. GUSTO moderate or severe bleeding

    Time frame: 7 days

    GUSTO moderate or severe bleeding up to 7 days after randomization

  6. VA-ECMO use

    Time frame: 7 days

    VA-ECMO use between randomization and day 7 after randomization

  7. Change in echocardiographic parameters

    Time frame: 24 hours

    Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization

  8. Days of ICU stay

    Time frame: 30 days

    Days of ICU stay

  9. Time to hemodynamic stabilization

    Time frame: 30 days

    Time to hemodynamic stabilization

Study contacts

Contact information is provided by the study sponsor or research team.

Holger Thiele, MD, Prof. Dr.

CONTACT

[email protected]

Karl Fengler, MD, Assoc. Prof.

CONTACT

[email protected]

+49 341 865-1426

Sponsors and collaborators

Lead sponsor

Leipzig Heart Science gGmbH

Other

Collaborators

  • Heart Center Leipzig at University of Leipzig
  • Helios Health Institute GmbH

Registry information

Official study title

A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Acronym: CATCH-PE II

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2024
Registry last updated
Mar 4, 2026

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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