Status:
RECRUITING
Acostream Use in Patients With High Risk and Intermediate-risk Acute Pulmonary Embolism
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Xiamen Cardiovascular Hospital, Xiamen University
Nantong University Affiliated Hospital
Conditions:
Pulmonary Embolism (PE)
Eligibility:
All Genders
18-85 years
Phase:
NA
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-di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT06946732
Start Date
April 1 2025
End Date
December 31 2026
Last Update
April 27 2025
Active Locations (1)
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1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200217