Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

Study Overview
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Brief Summary
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To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.

Official Title
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A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Thrombectomy Devices for the Treatment of Acute Pulmonary Embolism

Conditions
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PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism

Intervention / Treatment
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* Device: Stent-Retriever


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.RV/LV ratio ≥0.9; 4.Patients who agreed to participate in the study and voluntarily signed the informed consent. Exclusion Criteria: Patients with systolic blood pressure<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg; Patients with known severe pulmonary hypertension; Patients with Hematocrit <28%; Patients with known structural heart disease; Patients with left bundle branch block; Patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%; Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159 umol/L); Patients with known coagulopathy or bleeding tendency (platelet <100×109/L, or INR> 3); Patients who cannot receive antiplatelet or anticoagulant therapy; Patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure; Patients with intracardiac thrombosis; Patients treated with extracorporeal membrane oxygenation; Patients known to be allergic to contrast agents; Patients with diseases that may cause difficulty in treatment or evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate procedure, life expectancy less than one year, etc.); Females who are pregnant or in lactation; Patient is currently enrolled in another investigational study protocol; Other conditions not suitable for inclusion judged by the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent-Retriever arm<br>Device: Stent-Retriever | Device: Stent-Retriever<br>* all the participants in this group will be performed with Stent-Retriever<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in RV/LV ratio from baseline to 48 hours | Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first. | 48 hours post procedure | 
| Major Adverse Events from baseline to 48 hours | Endpoint events will be assessed from the time of treatment of the pulmonary embolism through hospital discharge, or through 48 hours post treatment, whichever comes first. | 48 hours post procedure |