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Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism
Sponsor: Qiu Jipeng
Summary
Acute pulmonary embolism (PE) is the third most common cardiovascular cause of death. In patients with intermediate-high risk acute PE, percutaneous mechanical thrombectomy (PMT) using large-bore catheters achieves rapid hemodynamic improvement while avoiding the bleeding risk of systemic thrombolysis, and low-dose catheter-directed thrombolysis (CDT) can dissolve residual thrombus with a lower systemic bleeding risk. This prospective, multicenter, non-randomized cohort study aims to compare the safety and efficacy of PMT alone versus PMT combined with low-dose CDT (PMT+LDCDT) in patients with acute intermediate-high risk PE. Approximately 150 patients will be enrolled and allocated to either PMT alone or PMT+LDCDT based on operator assessment. The primary safety endpoint is the composite incidence of major adverse events (MAE) within 48 hours, and the primary efficacy endpoint is the change in the right ventricular/left ventricular (RV/LV) diameter ratio from baseline to 48 hours assessed by a CTPA core laboratory.
Official title: A Prospective Cohort Study Comparing Percutaneous Mechanical Thrombectomy Alone Versus Percutaneous Mechanical Thrombectomy Combined With Low-Dose Catheter-Directed Thrombolysis in the Treatment of Acute Intermediate-High Risk Pulmonary Embolism
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-10-01
Completion Date
2031-12-31
Last Updated
2026-10-08
Healthy Volunteers
Yes
Conditions
Interventions
PMT alone (percutaneous mechanical thrombectomy only)
Percutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system)
PMT plus low-dose catheter-directed thrombolysis (PMT+LDCDT)
Low-dose catheter-directed thrombolysis: Alteplase (rt-PA), ≤20 mg (≤10 mg per lung), infused over ≤30 min via pulmonary artery catheter