Clinical trial NCT06946732: Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism
Official title: Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism (The ARTIST Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism (PE)
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Xiamen Cardiovascular Hospital, Xiamen University
name: Nantong University Affiliated Hospital
name: Chengdu University of Traditional Chinese Medicine
name: Shanghai No.1 Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Jinhua Central Hospital
First posted: 2025-04-27
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Change of RV/LV
timeFrame: 48 hours
Secondary outcomes:
measure: Surgical success rate
timeFrame: Immediately after surgery
measure: Changes in pulmonary artery pressure before and after surgery
timeFrame: 48 hours
measure: Changes in arterial oxygen pressure before and after surgery
timeFrame: 14 days
measure: Clinical deterioration incidence
timeFrame: 48 hours
measure: All-cause mortality rate
timeFrame: 1, 3, 6, 12 months
measure: Symptomatic PE recurrence rate
timeFrame: 1, 3, 6, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: