Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

PE - Pulmonary Thromboembolism Clinical Trial

— SRAME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05992168
• Other study ID #: SZZT-CP-202301
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: November 2023
• Source: Suzhou Zenith Vascular Scitech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 123
• Est. completion date: June 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• PE - Pulmonary Embolism
• PE - Pulmonary Thromboembolism
• Pulmonary Embolism
• Thromboembolism

Intervention

Device:
• Stent-Retriever
all the participants in this group will be performed with Stent-Retriever

Locations

Country	Name	City	State
China	Peking University People'S Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zenith Vascular Scitech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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