EKOS in Patients With Pulmonary Embolism (PE)

NCT06738108 | Completed

• 1 other identifier: ECOSII
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Embolism

Keywords

ECOS

Outcome Measures

Primary Outcomes (1)

• The change in RV/LV diameter ratio

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

  one month

Secondary Outcomes (1)

• All-cause 30-day readmission

  one month

Study Arms (2)

ECOS group

ECOS

Drug: ECOS

Control group

IV infusion tpa

Drug: Control group

Interventions

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

ECOS group

Control group DRUG

Alteplase IV infusion

Also known as: IV alteplase infusion

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Submassive PE was defined as having right ventricular (RV) dysfunction: detected via CT scan or echocardiography, with signs such as RV enlargement, RV hypokinesis, or RV/LV ratio \>0.9 to 1.0), elevated cardiac biomarkers like troponin or BNP, which indicate strain or injury to the heart muscle with a maintained blood pressure (SBP equal to or \> 90 mm Hg with no signs of shock. Massive PE was defined as SBP \<90 mm Hg for at least 15 minutes or require vasopressors to maintain adequate blood pressure with clinical signs of poor perfusion, including altered mental status, cool extremities, low urine output, or sudden loss of heart function due to obstructed blood flow from the pulmonary artery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Saudi German Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 17, 2024
• Study Start: December 13, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 8, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

EG (1)