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Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME) (SRAME)

Primary Purpose

PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stent-Retriever
Sponsored by
Suzhou Zenith Vascular Scitech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PE - Pulmonary Embolism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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: 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; Patient is currently enrolled in another investigational study protocol; Other conditions not suitable for inclusion judged by the researcher.

Sites / Locations

  • Peking University People'S Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stent-Retriever arm

Arm Description

Device: Stent-Retriever

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2023
Last Updated
August 8, 2023
Sponsor
Suzhou Zenith Vascular Scitech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05992168
Brief Title
Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 15, 2025 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zenith Vascular Scitech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate treatment outcomes of patients diagnosed with pulmonary embolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stent-Retriever arm
Arm Type
Experimental
Arm Description
Device: Stent-Retriever
Intervention Type
Device
Intervention Name(s)
Stent-Retriever
Intervention Description
all the participants in this group will be performed with Stent-Retriever
Primary Outcome Measure Information:
Title
Reduction in RV/LV ratio from baseline to 48 hours
Description
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.
Time Frame
48 hours post procedure
Title
Major Adverse Events from baseline to 48 hours
Description
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.
Time Frame
48 hours post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: 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; Patient is currently enrolled in another investigational study protocol; Other conditions not suitable for inclusion judged by the researcher.
Facility Information:
Facility Name
Peking University People'S Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Zhang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME)

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