Using Acostream for treating high-risk pulmonary embolism
Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 127 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06946732 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While catheter-directed therapies have been explored in other studies, this specific use of Acostream in this patient population is relatively novel.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qihong Ni
- Email: niqihong1989@163.com
- Phone: 15801900772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.