NCT06946732

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Embolism (PE)

Interventions

Type	Name	Description
DEVICE	Acostream aspiration	The pulmonary thrombus removal by Acostream.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: China