Clinical trial NCT06819865: A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism
Official title: EkoSonic Endovascular System in China RWS(ANTEATER)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Pulmonary Embolism
Keywords: PE
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: 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.

Detailed description: This is a multi-center, single arm, prospective, observational, real-world study.To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.

Up to 30 patients will be enrolled in this study and up to 30 patients will be enrolled in this study to observation safety and efficacy.

Eligibility criteria: Inclusion Criteria:

1. The patients with acute symptomatic pulmonary embolism (Symptomatic duration \< 14 days).
2. The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
3. Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.

Exclusion Criteria:

1. The patients with acute symptomatic pulmonary embolism (Symptomatic duration \< 14 days).
2. The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
3. Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.

Primary outcomes:
measure: RV vs LV end-diastolic diameter ratio
timeFrame: after the completion of EKOS treatment 48 hours compared with the baseline
Secondary outcomes:
measure: RV vs LV end-diastolic diameter ratio
timeFrame: 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
measure: PE events after the completion of EKOS treatment
timeFrame: 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
measure: Serious adverse events related to EKOS or procedure
timeFrame: After enrollment to end of study，through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Guangqi Chang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: