Catheter-interventional Treatment of Pulmonary Embolism (CATCH-PE)

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: combined catheter-thrombectomy and local fibrinolysis; Other: conventional treatment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Heart Center Leipzig at University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined interventional treatment; Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment	Device: combined catheter-thrombectomy and local fibrinolysis; combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment
Active Comparator: conventional treatment; Conventional treatment	Other: conventional treatment; conventional treatment of pulmonary embolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RV-LV-Ratio	Change in right to left ventricular diameter ratio	Day 1 after randomization
clinical efficacy	quotient of systolic systemic blood pressure over heart rate and respiratory rate	Day 1 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	difference in mortality between the treatment groups	1 day, 30 days, 1 year after randomization
Right heart failure	difference in new onset right heart failure between the groups	30 days and 1 year after randomization
pulmonary artery pressure	difference in estimated pulmonary artery pressure between the groups	1 day, 30 days and 1 year after randomization
RV/LV-ratio	difference in RV/LV-ratio	30 days and 1 year after randomization
Bleeding	difference in BARC bleeding events between the groups	1 day, 30 days and 1 year after randomization
Troponin and NT-proBNP	difference in high-sensitivity Troponin T and NT-proBNP between the groups	30 days and 1 year after randomization
TAPSE	difference in TAPSE as assessed by transthoracic echocardiogram	1 day, 30 days and 1 year after randomization
difference in RA volume between the groups	RA volume between the groups	1 day, 30 days and 1 year after randomization

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): October 10, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: July 9, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Pulmonary Embolism; Embolism
• Other Study ID Numbers: CATCH-PE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No