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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined interventional treatment | Experimental | Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment |
|
| conventional treatment | Active Comparator | Conventional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined catheter-thrombectomy and local fibrinolysis | Device | combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Leipzig at University of Leipzig | Leipzig | Saxony | 04289 | Germany |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| conventional treatment | Other | conventional treatment of pulmonary embolism |
|
| 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 | 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 |
| 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 |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |