Stent-Retriever for Acute Massive Pulmonary Embolism (SRAME) | NCT05992168

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

NCT05992168

Sponsor

Suzhou Zenith Vascular Scitech Co., Ltd.

Status

Terminated

Last Update Posted

Sep 18, 2025Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

PE - Pulmonary Embolism
PE - Pulmonary Thromboembolism

Interventions

Stent-Retriever

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The clinical trial was terminated ahead of schedule due to strategic changes within the company.

Expanded Access Info

Start Date

Jan 3, 2024Actual

Primary Completion Date

Dec 17, 2024Actual

Completion Date

Dec 17, 2024Actual

First Submitted Date

Aug 8, 2023

First Submission Date that Met QC Criteria

Aug 8, 2023

First Posted Date

Aug 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2025

Last Update Posted Date

Sep 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
Stent-Retriever arm	Experimental	Device: Stent-Retriever	Device: Stent-Retriever

Name	Type	Description	Arm Group Labels	Other Names
Stent-Retriever	Device	all the participants in this group will be performed with Stent-Retriever	Stent-Retriever arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis