Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

NCT05992168 | Terminated

• 1 other identifier: SZZT-CP-202301
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.

Conditions

PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Stent-Retriever arm

EXPERIMENTAL

Device: Stent-Retriever

Device: Stent-Retriever

Interventions

Stent-Retriever DEVICE

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

Stent-Retriever arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou Zenith Vascular Scitech Co., Ltd.: lead

Study Sites (1)

Peking University People'S Hospital

Beijing, China

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: January 3, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)