Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism
1 other identifier
interventional
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 19, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 27, 2025
April 1, 2025
9 months
April 19, 2025
April 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change of RV/LV
The ratio of right ventricular diameter to left ventricular diameter (RV/LV) decreased compared to baseline
48 hours
Secondary Outcomes (6)
Surgical success rate
Immediately after surgery
Changes in pulmonary artery pressure before and after surgery
48 hours
Changes in arterial oxygen pressure before and after surgery
14 days
Clinical deterioration incidence
48 hours
All-cause mortality rate
1, 3, 6, 12 months
- +1 more secondary outcomes
Study Arms (1)
The Acostream aspiration group
EXPERIMENTALThe pulmonary thrombus removal by Acostream.
Interventions
The pulmonary thrombus removal by Acostream.
Eligibility Criteria
You may qualify if:
- ≤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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
- Xiamen Cardiovascular Hospital, Xiamen Universitycollaborator
- Nantong University Affiliated Hospitalcollaborator
- Chengdu University of Traditional Chinese Medicinecollaborator
- Shanghai No.1 Hospitalcollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Jinhua Central Hospitalcollaborator
Study Sites (1)
Renji Hospital
Shanghai, Shanghai Municipality, 200217, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2025
First Posted
April 27, 2025
Study Start
April 1, 2025
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
April 27, 2025
Record last verified: 2025-04