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Recruiting NCT06946732

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

Trial Parameters

Condition Pulmonary Embolism (PE)
Sponsor RenJi Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 127
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2025-04-01
Completion 2025-12-31
Interventions
Acostream aspiration

Brief 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 Criteria

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.

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