Catheter-interventional Treatment of Pulmonary Embolism

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: combined catheter-thrombectomy and local fibrinolysis
* Other: conventional treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 
| TAPSE | TAPSE as assessed by transthoracic echocardiogram | 1 day, 30 days and 1 year after randomization | 
| RA volume between the groups | RA volume between the groups | 1 day, 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 |