Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

Suzhou Zenith Vascular Scitech

Status: Terminated

Conditions: PE - Pulmonary Thromboembolism; PE - Pulmonary Embolism

Treatments: Device: Stent-Retriever

Study type: Interventional

Funder types: Industry

Identifiers

NCT05992168

SZZT-CP-202301

Details and patient eligibility

About

To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Stent-Retriever arm

Experimental group

Description:

Device: Stent-Retriever

Treatment:

Device: Stent-Retriever