Actively Recruiting
Study of Acostream Catheter-Directed Aspiration for High and Intermediate-High Risk Acute Pulmonary Embolism
Led by RenJi Hospital · Updated on 2025-04-27
127
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and feasibility of using a device called Acostream for catheter-directed aspiration in patients with high-risk and intermediate-high-risk pulmonary embolism. The study is observational and will involve 130 patients across multiple centers in China. The main goal is to assess how well the device removes blood clots in the lungs and its impact on heart strain, vessel blockage, overall patient improvement, and early death rates due to pulmonary embolism. Participants will undergo pulmonary thrombus removal using the Acostream device. The study does not include a comparison group and focuses on the effects of this single intervention. The treatment is delivered through catheter-directed thrombectomy to physically remove clots from the pulmonary arteries. During the study, participants will be monitored through various assessments including heart strain measurements at 48 hours, pulmonary artery pressure changes, oxygen levels before and after treatment, and clinical deterioration within 48 hours. Researchers will also track mortality rates and recurrence of pulmonary embolism at 1, 3, 6, and 12 months. The total participation time includes immediate post-treatment evaluation and follow-up over one year to monitor outcomes and safety.
CONDITIONS
Brief Title
Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism
Research Team
Q
Qihong Ni
M
Meng Ye
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