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NOT YET RECRUITING
NCT07865572
NA

Percutaneous Mechanical Thrombectomy With or Without Low-Dose Catheter-Directed Thrombolysis in Acute Intermediate-High Risk Pulmonary Embolism

Sponsor: Qiu Jipeng

View on ClinicalTrials.gov

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

Interventions

DEVICE

PMT alone (percutaneous mechanical thrombectomy only)

Percutaneous mechanical thrombectomy system (e.g., FlowTriever, Indigo aspiration system)

DEVICE

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