Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism

April 19, 2025 updated by: RenJi Hospital

Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)

The registry is to evaluate the safety and feasibility of catheter-directed aspiration for patients with high-risk and intermediate-high-risk pulmonary embolism using Acostream.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The registry is a prospective, multicenter, observational study involving 130 patients across up to seven sites in China. The aim of this study is to evaluate the safety and feasibility of catheter-directed thrombectomy using Acostream in patients with high-risk and intermediate-high-risk pulmonary embolism. The primary endpoint of the study is the efficacy and safety of pulmonary thrombus removal, assessed by reduction of ventricular strain, decrease in vascular obstruction, overall clinical improvement, and the early mortality rate from pulmonary embolism. Secondary endpoints include the total mortality rate of PE and the incidence of complications in the procedure.

Study Type

Interventional

Enrollment (Estimated)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Acostream aspiration group
The pulmonary thrombus removal by Acostream.
Device: Acostream aspiration
The pulmonary thrombus removal by Acostream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of RV/LV
Time Frame: 48 hours
The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical success rate
Time Frame: Immediately after surgery
Immediately after surgery
Changes in pulmonary artery pressure before and after surgery
Time Frame: 48 hours
48 hours
Changes in arterial oxygen pressure before and after surgery
Time Frame: 14 days
14 days
Clinical deterioration incidence
Time Frame: 48 hours
Clinical deterioration incidence includes tracheal intubation, mechanical ventilation, arterial hypotension>1 hour or shock, cardiopulmonary resuscitation, significant deterioration of oxygenation, and emergency surgical thrombectomy)
48 hours
All-cause mortality rate
Time Frame: 1, 3, 6, 12 months
1, 3, 6, 12 months
Symptomatic PE recurrence rate
Time Frame: 1, 3, 6, 12 months
1, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

First Affiliated Hospital of Fujian Medical University
Chengdu University of Traditional Chinese Medicine
Jinhua Central Hospital
Xiamen Cardiovascular Hospital, Xiamen University
Nantong University Affiliated Hospital
Shanghai No.1 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The ARTIST study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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