Pulmonary Embolism With Acute Cor Pulmonale Clinical Trial
Official title:
Continuous Aspiration Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism Patients
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism
may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In
high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development
of interventional cardiology has made catheter-directed techniques an important alternative
to thrombolytic therapy. The controversy concerns also risk stratification and treatment in
intermediate-high risk pulmonary embolism patients. A significant percentage of
intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic
deterioration and then the prognosis in this group is significantly worse. Catheter-directed
techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus
increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed
approaches in high-risk and intermediate-high risk pulmonary embolism patients.
Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism
may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In
high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development
of interventional cardiology has made catheter-directed techniques an important alternative
to thrombolytic therapy. The controversy concerns also risk stratification and treatment in
intermediate-high risk pulmonary embolism patients. A significant percentage of
intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic
deterioration and then the prognosis in this group is significantly worse. Catheter-directed
techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus
increasing cardiac output and immediately restoring hemodynamic stability.
The scope of this study is to evaluate the safety and feasibility of catheter-directed
approaches in high-risk and intermediate-high risk pulmonary embolism patients.
The primary data recorded include details of each patient's clinical status, co-morbidities
with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results
of additional studies (lab tests results, electrocardiogram, imaging studies), and the
outcome. The study endpoints comprise technical success, clinically relevant
procedure-related complications or bleeding events, classified according to the Valve
Academic Research Consortium-2 guidelines criteria.
Collecting the fore mentioned data allows for clinicians to better manage the pulmonary
embolism patients with increased mortality risk.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04879069 -
Polish Multicenter PERTs PE Outcomes Registry
|
||
| Terminated |
NCT03988842 -
Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism
|
Phase 4 |