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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Pulmonary Embolism (PE)

Treatments: Device: Acostream aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT06946732

The ARTIST study

Details and patient eligibility

About

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.

Full description

The registry is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The aim of this study is to evaluate the safety and feasibility of catheter-directed thrombectomy using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. The primary endpoint of the study is the efficacy and safety of pulmonary thrombus removal, assessed by reduction of ventricular strain, decrease in vascular obstruction, overall clinical improvement, and the early mortality rate from pulmonary embolism. Secondary endpoints include the total mortality rate of PE and the incidence of complications in the procedure.

Enrollment: 127 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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127 participants in 1 patient group

The Acostream aspiration group

Experimental group

Description:

The pulmonary thrombus removal by Acostream.

Treatment:

Device: Acostream aspiration