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Recruiting Not applicable

Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism

NCT06946732 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2025-04-27

Condition(s) studied

Pulmonary Embolism (PE)

Investigational drug(s) / intervention(s)

Acostream aspiration

Acostream aspiration: The pulmonary thrombus removal by Acostream.

Study summary

The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 18≤Age≤85 * Clinical symptoms and presentation consistent with pulmonary embolism (PE). * PE symptoms duration ≤ 14 days. * High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy. * Intermediate-high risk PE patients with right ventricle dysfunction (right ventricle/ left ventricle \>0.9) confirmed by computed tomography pulmonary angiography or transthoracic echocardiography. Exclusion Criteria: * Pregnancy. * Refusal to sign the informed consent form. * Presence of intracardiac thrombus. * Presence of chronic left heart failure with an ejection fraction lower than 30% Diagnosed thrombophilia. * History of severe or chronic pulmonary hypertension. * Serum creatinine level higher than 1.8 mg/dl. * Known serious and uncontrolled sensitivity to radiographic agents.

Primary outcome measure(s)

  • Change of RV/LV — 48 hours
    The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline

Trial sites (1)

FacilityCityRegionStatus
Renji Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06946732 on ClinicalTrials.gov ↗ ← All trials in China