Using Acostream for treating high-risk pulmonary embolism
Official title: Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
Run by RenJi Hospital · NCT06946732 · Data updated 2026-11-12
This study is testing if a new method using Acostream can safely remove blood clots in patients with high-risk pulmonary embolism to help them feel better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 127 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | April 27, 2025 |
| Trial ID | NCT06946732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 85 with high-risk or intermediate-high-risk pulmonary embolism and specific contraindications to systemic thrombolysis.
✕Probably not a fit
Patients with chronic left heart failure, severe pulmonary hypertension, or those with contraindications to the procedure will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry evaluates the safety and feasibility of catheter-directed aspiration using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. It is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The primary focus is on the efficacy and safety of pulmonary thrombus removal, measured by various clinical outcomes including reduction of ventricular strain and overall clinical improvement. Secondary endpoints will assess total mortality rates and complications associated with the procedure.
Why it matters
Potential benefit: If successful, this approach could provide a safer treatment option for patients with high-risk pulmonary embolism who cannot undergo traditional thrombolysis or surgery.
How similar studies have gone: While catheter-directed therapies have been explored in other studies, this specific use of Acostream in this patient population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Renji Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Qihong Ni
- Email: niqihong1989@163.com
- Phone: 15801900772
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pulmonary Embolism Registry from Emergency Care to Long-Term Follow-Up
This registry follows adults with acute pulmonary embolism to see how care is given in the real world and what happens over time.
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Pulmonary embolism with right-to-left heart or lung shunts
This project will see if people with an acute pulmonary embolism who also have a right-to-left shunt (like a PFO or ASD) are more likely to have a stroke than PE patients without a shunt.
-
Repeated exams to classify early pulmonary embolism
This project will test whether doing repeated blood tests, ECGs, and bedside heart ultrasounds during the first 48 hours after pulmonary embolism helps predict who will get worse in adults treated at Sahlgrenska University Hospital.
-
Ultrasound-guided catheter clot-dissolving treatment for adults with moderate-to-high risk pulmonary embolism
This trial will try ultrasound-guided catheter thrombolysis (EKOS) to see if it is safe and helps adults with intermediate-high or high-risk pulmonary embolism.
-
Evaluating and improving diagnostics and management of venous thromboembolism
This study is trying to find better ways to diagnose and manage blood clots in the veins for older patients who might have deep vein thrombosis or pulmonary embolism.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.