Catheter-interventional Treatment of Pulmonary Embolism

Not Applicable

Completed

• Conditions: Pulmonary Embolism
• Interventions: Other: conventional treatment; Device: combined catheter-thrombectomy and local fibrinolysis

• Registration Number: NCT05456789
• Lead Sponsor: Heart Center Leipzig - University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-07-09
• Study First Posted: 2022-07-13
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	conventional treatment	Conventional treatment
Combined interventional treatment	combined catheter-thrombectomy and local fibrinolysis	Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Heart Center Leipzig at University of Leipzig; 🇩🇪 Leipzig, Saxony, Germany