Catheter-interventional Treatment of Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— CATCH-PE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05456789
• Other study ID #: CATCH-PE
• Status: Recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: June 2025

Study information

• Verified date: July 2022
• Source: Heart Center Leipzig - University Hospital
• Contact: Karl Fengler
• Phone: +493418651427
• Email: Karl.Fengler[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• combined catheter-thrombectomy and local fibrinolysis
combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment

Other:
• conventional treatment
conventional treatment of pulmonary embolism

Locations

Country	Name	City	State
Germany	Heart Center Leipzig at University of Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RV-LV-Ratio	Change in right to left ventricular diameter ratio	Day 1 after randomization
Primary	clinical efficacy	quotient of systolic systemic blood pressure over heart rate and respiratory rate	Day 1 after randomization
Secondary	Mortality	difference in mortality between the treatment groups	1 day, 30 days, 1 year after randomization
Secondary	Right heart failure	difference in new onset right heart failure between the groups	30 days and 1 year after randomization
Secondary	pulmonary artery pressure	difference in estimated pulmonary artery pressure between the groups	1 day, 30 days and 1 year after randomization
Secondary	RV/LV-ratio	difference in RV/LV-ratio	30 days and 1 year after randomization
Secondary	TAPSE	TAPSE as assessed by transthoracic echocardiogram	1 day, 30 days and 1 year after randomization
Secondary	RA volume between the groups	RA volume between the groups	1 day, 30 days and 1 year after randomization
Secondary	Bleeding	difference in BARC bleeding events between the groups	1 day, 30 days and 1 year after randomization
Secondary	Troponin and NT-proBNP	difference in high-sensitivity Troponin T and NT-proBNP between the groups	30 days and 1 year after randomization