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OpenTrials
Completed

NCT Number: NCT06738108

EKOS in Patients With Pulmonary Embolism (PE)

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saudi German Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years diagnosed with massive or submassive acute PE.

Exclusion criteria

  • Patients presented with stable PE
  • Patients did not receive EKOS intervention.

Treatment and study plan

ECOS

Drug

The EkoSonic Endovascular System, developed by EKOS Corporation, is a specialized CDT system that combines ultrasound technology with thrombolytic infusion to treat PE

Control group

Drug

Alteplase IV infusion

Other names: IV alteplase infusion

Primary outcomes

  1. The change in RV/LV diameter ratio

    Time frame: one month

    The change in RV/LV diameter ratio from baseline to first outpatient follow-up as documented on an echocardiogram.

Secondary outcomes

  1. All-cause 30-day readmission

    Time frame: one month

    All-cause 30-day readmission

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Safety and Effectiveness of EKOS in PE Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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