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NOT YET RECRUITING
NCT07869875
NA

Comparing Three Catheter Aspiration Strategies for Intermediate-High-Risk Acute Pulmonary Embolism

Sponsor: Qiu Jipeng

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.