Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism (NCT04473560) | Clinical Trial Compass
UnknownNot Applicable
Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism
Poland100 participantsStarted 2018-10-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Clinical symptoms and presentation consistent with pulmonary embolism (PE).
✓. PE symptoms duration ≤ 14 days.
✓. High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.
✓. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:
✓. Arterial blood saturation \<90% during spontaneous breathing (atm)
✓. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:
Exclusion criteria
What they're measuring
1
Reduction of pulmonary arterial pressures
Timeframe: Immediately after catheter-directed thrombectomy procedure
2
Reduction of vascular obstruction
Timeframe: Immediately after catheter-directed thrombectomy procedure
3
Clinical improvement during catheter-directed thrombectomy (CDT) procedure
Timeframe: Immediately after catheter-directed thrombectomy procedure
4
Ventricular strain reduction
Timeframe: 24 hours after catheter-directed thrombectomy
5
Early mortality rate from pulmonary embolism
Timeframe: 24 hours after catheter-directed thrombectomy