Actively Recruiting
Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
Led by RenJi Hospital · Updated on 2025-04-27
127
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
X
Xiamen Cardiovascular Hospital, Xiamen University
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Clinical symptoms and presentation consistent with pulmonary embolism
- Pulmonary embolism symptoms lasting 14 days or less
- High-risk pulmonary embolism patients who cannot have systemic thrombolysis or have failed it and are not eligible for surgical embolectomy
- Intermediate-high-risk pulmonary embolism patients with right ventricle dysfunction confirmed by imaging
You will not qualify if you...
- Pregnancy
- Refusal to sign informed consent
- Presence of intracardiac thrombus
- Chronic left heart failure with ejection fraction below 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure and immediate post-procedure period
Participants undergo pulmonary thrombus removal using the Acostream device.
1 visit (procedure day) plus approximately 1 follow-up visit within 48 hours
Duration - Up to 12 months
Participants are monitored for clinical improvement, changes in pulmonary artery pressure and arterial oxygen pressure, and adverse events following the procedure.
Multiple visits at 14 days, 1 month, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200217
Actively Recruiting
Research Team
Q
Qihong Ni
M
Meng Ye
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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