RecruitingNot ApplicableNCT06946732

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

Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)

Sponsor

RenJi Hospital

Enrollment

127 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Embolism (PE)

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

≤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 Criteria7

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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