Clinical trial Recruiting at 1 site Interventional Ages 18 to 85

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 typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment127 (estimated)
SponsorRenJi Hospital
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedApril 1, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedApril 27, 2025
Trial IDNCT06946732 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.