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Recruiting NCT06946732

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

No phase Interventional Pulmonary Embolism (PE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acostream aspiration.
Who it may be relevant to
Registry conditions: Pulmonary Embolism (PE). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device Acostream aspiration
    The pulmonary thrombus removal by Acostream.

Primary outcome measures

  • Change of RV/LV [Time frame: 48 hours]
Secondary outcome measures (6)
  • Surgical success rate [Time frame: Immediately after surgery]
  • Changes in pulmonary artery pressure before and after surgery [Time frame: 48 hours]
  • Changes in arterial oxygen pressure before and after surgery [Time frame: 14 days]
  • Clinical deterioration incidence [Time frame: 48 hours]
  • All-cause mortality rate [Time frame: 1, 3, 6, 12 months]
  • Symptomatic PE recurrence rate [Time frame: 1, 3, 6, 12 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Identifiers

NCT: NCT06946732 · The ARTIST study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗