NCT06738108

EKOS in Patients With Pulmonary Embolism (PE)

Safety and Effectiveness of EKOS in PE Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital.

Detailed description

A retrospective cohort study assessed patients who underwent EKOS intervention following the failure of initial therapeutic anticoagulation for managing acute pulmonary embolism at a tertiary hospital. Patients aged at least 18 years with a diagnosis of submassive or massive acute PE were included. Patients were excluded if they either did not receive EKOS intervention or were presented with stable PE. The primary outcome was the change in RV/LV diameter ratio from baseline to first outpatient follow-up.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	ECOS	The EkoSonic Endovascular System, developed by EKOS Corporation, is a specialized CDT system that combines ultrasound technology with thrombolytic infusion to treat PE
DRUG	Control group	Alteplase IV infusion

Timeline

• Start date: 2024-12-13
• Primary completion: 2024-12-20
• Completion: 2025-01-08
• First posted: 2024-12-17
• Last updated: 2025-01-09

Locations

1 site across 1 country: Egypt