Pulmonary EmbolismNCT06738108
EKOS in Patients With Pulmonary Embolism (PE)
An observational study of Pulmonary Embolism, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- ECOS
- Type of treatment
- Injection or infusion
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Dec 2024to 8 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients ≥ 18 years diagnosed with massive or submassive acute PE.
Who cannot join
- Patients presented with stable PE
- Patients did not receive EKOS intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of EKOS in PE Patients
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.
Read the 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
- Being tested
- ECOS, Control group
- Keywords
- ECOS
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECOSDrug
The EkoSonic Endovascular System, developed by EKOS Corporation, is a specialized CDT system that combines ultrasound technology with thrombolytic infusion to treat PE
Control groupDrug
Also called IV alteplase infusion
Alteplase IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ECOS group | ECOS Receives: Drug: ECOS | |
| Control group | IV infusion tpa Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (1)
All-cause 30-day readmission
All-cause 30-day readmission
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start13 Dec 2024
- Primary completion20 Dec 2024
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelfattah Elsayed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738108
- Sponsor's protocol ID
- ECOSII
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of EKOS in PE Patients
- ClinicalTrials.gov ID
- NCT06738108
- Acronym / sponsor ID
- ECOSII
- Conditions
- Pulmonary Embolism
- Keywords
- ECOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECOS group | – | Drug: ECOSECOS |
| Control group | – | Drug: Control groupIV infusion tpa |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients ≥ 18 years diagnosed with massive or submassive acute PE.
Key exclusion criteria (2 listed)
- Patients presented with stable PE
- Patients did not receive EKOS intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECOSThe EkoSonic Endovascular System, developed by EKOS Corporation, is a specialized CDT system that combines ultrasound technology with thrombolytic infusion to treat PE | Drug | ECOS group |
| Control groupAlso: IV alteplase infusionAlteplase IV infusion | Drug | Control group |
Primary outcome
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.
1 secondary outcome
All-cause 30-day readmission
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in RV/LV diameter ratio (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.