Health TrialsbyHealthPanel

A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism

ConditionAcute Pulmonary Embolism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).

The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image

Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.

Disqualifiers

The patients with acute symptomatic pulmonary embolism (Symptomatic duration < 14 days).

The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image

Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.

Trial population

This study will enroll patients who received EkoSonicTM Endovascular System treatment with r-tPA for acute pulmonary thromboembolism, and who could provide sufficient echocardiographic quality to assess the collection of primary endpoint, and prospectively collect the clinical data related to the protocol in the actual clinical diagnosis and treatment

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • EkoSonicTM Endovascular System

    Device

    EkoSonicTM Endovascular System and its upgraded versions if applicable The EkoSonicTM Endovascular System is a non-implanted system comprising a sterile, single-use EkoSonic Endovascular Device (Infusion Catheter and Ultrasonic Core) and reusable EKOSTM Control System 4.0(Control Unit, Connector Interface Cable and power cord).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single group observational study1 intervention

Trial outcomes

Primary outcomes

1

RV vs LV end-diastolic diameter ratio

The change in the right ventricular end-diastolic diameter to left ventricle end-diastolic diameter ratio at 48hours after the completion of EKOS treatment compared with the baseline.

Time frame
after the completion of EKOS treatment 48 hours compared with the baseline

Secondary outcomes

1

RV vs LV end-diastolic diameter ratio

The change in the right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio at 24h, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline.

Time frame
after the completion of EKOS treatment 24 hours, Discharge(Approximately within 15 days after completed treatment) , after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline，through study completion, an average of 1 year
2

PE events after the completion of EKOS treatment

Recurrent symptomatic PE events after the completion of EKOS treatment.

Time frame
After the completion of EKOS treatment 24hours, 48hours,Discharge(Approximately within 15 days after completed treatment), after the completion of EKOS treatment Month 1, Month 3, Month 6, compared to the baseline
3

Serious adverse events related to EKOS or procedure

All of SAE related to EKOS or procedure

Time frame
After enrollment to end of study，through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Scientific Corporation

Lead sponsor

Source ClinicalTrials.gov
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