Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

Launched by SUZHOU ZENITH VASCULAR SCITECH CO., LTD. · Aug 8, 2023

Keywords

ClinConnect Summary

The SRAME clinical trial is designed to study a new treatment method for patients diagnosed with pulmonary embolism (PE), which is a serious condition where blood clots block the blood vessels in the lungs. The goal of this trial is to evaluate how effective this treatment is in clearing these clots and improving patient outcomes. The trial is currently not recruiting participants, but when it starts, it will accept individuals aged between 18 and 75, regardless of gender, who have been diagnosed with acute pulmonary embolism and need a specific type of treatment to remove the clots.

To be a part of this study, patients must meet certain criteria, such as having a specific heart condition related to the PE and being able to agree to participate by signing a consent form. However, there are several factors that could exclude someone from participating, including low blood pressure, severe heart or lung issues, or certain other health conditions. Participants will undergo a procedure to treat their condition, and the study will help researchers understand how well this new approach works in treating severe pulmonary embolism.

Gender

ALL

Eligibility criteria

• 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.