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Comparing Three Catheter Aspiration Strategies for Intermediate-High-Risk Acute Pulmonary Embolism
Sponsor: Qiu Jipeng
Summary
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.
Official title: Safety and Effectiveness of Different-Size Percutaneous Catheter Aspiration Strategies in Patients With Intermediate-High-Risk Acute Pulmonary Embolism: A Prospective, Multicentre, Open-Label Observational Cohort Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2026-10-04
Completion Date
2031-12-31
Last Updated
2026-10-13
Healthy Volunteers
Yes
Conditions
Interventions
Small-bore (8-12 F) percutaneous catheter aspiration
Continuous 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
Mechanical 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
Sequential 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.