Acute pulmonary embolism (PE) is a serious and potentially life-threatening condition in which blood clots block the arteries of the lungs. For patients with intermediate-high-risk PE, doctors may remove the clots through a thin tube (catheter) placed into the lung arteries, a procedure called percutaneous catheter aspiration.
Two main types of catheters are used. Small-bore catheters (8-12 French) are easier to guide into the smaller, more distant branches of the lung arteries, but they remove large central clots less efficiently. Large-bore catheters (16 French or larger) remove central clots more effectively, but are harder to advance into the smaller branches. Some doctors use both types together, starting with a large-bore catheter for the central clot and then a small-bore catheter for the remaining distal clot. It is not yet known which of these three approaches is safest and works best.
This study will follow about 225 adults with intermediate-high-risk acute PE who are treated with catheter aspiration at five hospitals in China. Participants are grouped according to the catheter strategy that was actually used during their routine care: small-bore aspiration only, large-bore aspiration only, or combined large-bore plus small-bore aspiration. Information is collected from routine hospital tests, CT scans, echocardiograms, procedure records, and follow-up visits at 24 hours, 48 hours, 7 days, 30 days, and 90 days after the procedure. The study does not require any extra invasive tests or procedures.
The main goals are to compare, among the three groups: (1) the rate of major adverse events within 7 days after the procedure, and (2) the improvement in right-heart strain seen on CT scans 48 hours after the procedure. The results may help doctors choose the most suitable catheter strategy for patients with intermediate-high-risk acute PE.
Age 18 to 80 years.
Acute pulmonary embolism confirmed by computed tomography pulmonary angiography (CTPA).
Interval from symptom onset to diagnosis of 14 days or less.
Intermediate-high-risk PE according to the 2025 Chinese guideline and ESC risk stratification: simplified Pulmonary Embolism Severity Index (sPESI) of 1 or greater; imaging evidence of right ventricular dysfunction (CTPA RV/LV diameter ratio >= 1.0, or echocardiographic right ventricular dilatation or hypokinesia); and troponin I or T above the upper limit of normal.
Haemodynamic instability at enrolment: cardiac arrest; need for ongoing cardiopulmonary resuscitation; or systolic blood pressure below 80 mmHg for more than 15 minutes unresponsive to fluid resuscitation and vasopressors.
Active bleeding; known coagulopathy (INR > 2.0 or platelet count < 50 x 10^9/L); intracranial haemorrhage within the previous 90 days, or intracranial tumour or vascular malformation; major surgery, major trauma, or gastrointestinal bleeding within the previous 30 days; known heparin allergy or history of heparin-induced thrombocytopenia.
Planned catheter-directed thrombolysis or systemic thrombolysis.
Known chronic thromboembolic pulmonary hypertension; severe left ventricular dysfunction (LVEF < 30%); severe valvular heart disease (moderate-to-severe aortic stenosis or mitral regurgitation); end-stage renal disease (eGFR < 30 mL/min/1.73 m2 or dialysis dependence); pregnancy or breastfeeding.
Parallel
Small-bore (8-12 F) percutaneous catheter aspiration
DeviceContinuous or intermittent vacuum aspiration through a small-bore (8-12 F) catheter positioned in the pulmonary arteries to remove thrombus. Catheter selection, access site, and aspiration technique follow the treating centre's standard practice.
Large-bore (16 F or larger) percutaneous catheter aspiration thrombectomy
DeviceMechanical aspiration-thrombectomy using a large-bore (16 F or larger) catheter system positioned in the pulmonary arteries to remove central thrombus. Device selection and technique follow the treating centre's standard practice.
Combined large-bore and small-bore percutaneous catheter aspiration
DeviceSequential use of a large-bore (16 F or larger) catheter to debulk central thrombus, followed by a small-bore (8-12 F) catheter to aspirate residual distal thrombus within the same procedure.
Composite Major Adverse Events Within 7 Days After the Procedure
Change in Right Ventricular to Left Ventricular (RV/LV) Diameter Ratio on CTPA From Baseline to 48 Hours After the Procedure
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Qiu Jipeng
Lead sponsor
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Sponsor institution
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