Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

Not Applicable

Not yet recruiting

• Conditions: PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism
• Interventions: Device: Stent-Retriever

• Registration Number: NCT05992168
• Lead Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.

Brief Summary

To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Study Start: 2023-12-15
• Primary Completion: 2025-01-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 123

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

1. Patients with systolic blood pressure<90 mmHg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmHg;
2. Patients with known severe pulmonary hypertension;
3. Patients with Hematocrit <28%;
4. Patients with known structural heart disease;
5. Patients with left bundle branch block;
6. Patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%;
7. Patients with abnormal renal function (serum creatinine > 1.8 mg/dL or >159 umol/L);
8. Patients with known coagulopathy or bleeding tendency (platelet <100×109/L, or INR> 3);
9. Patients who cannot receive antiplatelet or anticoagulant therapy;
10. Patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure;
11. Patients with intracardiac thrombosis;
12. Patients treated with extracorporeal membrane oxygenation;
13. Patients known to be allergic to contrast agents;
14. 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.);
15. Females who are pregnant or in lactation;
16. Patient is currently enrolled in another investigational study protocol;
17. Other conditions not suitable for inclusion judged by the researcher.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent-Retriever arm	Stent-Retriever	Device: Stent-Retriever

Primary Outcome Measures

Name	Time	Method
Reduction in RV/LV ratio from baseline to 48 hours	48 hours post procedure	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.
Major Adverse Events from baseline to 48 hours	48 hours post procedure	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.

Trial Locations

Locations (1)

Peking University People'S Hospital; 🇨🇳 Beijing, China