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

Study acronym: PMT-LDCDT-PE
StatusNot Yet Recruiting
PhaseNot applicable
SponsorQiu Jipeng
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07865572
Lead Sponsor Qiu Jipeng
Conditions
(from sponsor)
Acute Pulmonary Embolism
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov