The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.
The registry is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The aim of this study is to evaluate the safety and feasibility of catheter-directed thrombectomy using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. The primary endpoint of the study is the efficacy and safety of pulmonary thrombus removal, assessed by reduction of ventricular strain, decrease in vascular obstruction, overall clinical improvement, and the early mortality rate from pulmonary embolism. Secondary endpoints include the total mortality rate of PE and the incidence of complications in the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
127
The pulmonary thrombus removal by Acostream.
Renji Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChange of RV/LV
The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline
Time frame: 48 hours
Surgical success rate
Time frame: Immediately after surgery
Changes in pulmonary artery pressure before and after surgery
Time frame: 48 hours
Changes in arterial oxygen pressure before and after surgery
Time frame: 14 days
Clinical deterioration incidence
Clinical deterioration incidence includes tracheal intubation, mechanical ventilation, arterial hypotension\>1 hour or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical thrombectomy)
Time frame: 48 hours
All-cause mortality rate
Time frame: 1, 3, 6, 12 months
Symptomatic PE recurrence rate
Time frame: 1, 3, 6, 12 months
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