Safety and Efficacy of SINOMED SR for Endovascular Treatm... | NCT04973332

Status Module

Name	Class
The General Hospital of Eastern Theater Command	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thrombectomy-SINOMED SR	Experimental	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.	Device: Intracranial thrombectomy stent
Thrombectomy-Solitaire FR	Active Comparator	Intracranial thrombectomy was performed with a control product（name:Solitaire FR）	Device: Intracranial thrombectomy stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intracranial thrombectomy stent	Device	Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset	Thrombectomy-SINOMED SR Thrombectomy-Solitaire FR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Successful Immediate Recanalization	The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade	Within 24 hours post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery	The Modified Rankin Scale is a global measure of functional disability ranging from 0 (no symptoms) to 6 (death), where lower scores indicate a better outcome. A score of 0-2 is commonly interpreted as a favorable functional outcome.	pre-procedure, and 90 days post-procedure

Eligibility Module

Eligibility Criteria

General inclusion criteria：

18 years old or more;
NIHSS≥6 during randomization;
Pre-onset MRS < 2;
Acute ischemic stroke was diagnosed;
Within 24 hours from the onset of stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed;The time point of stroke onset was defined as the time point at which the patient's last normal condition was known;
The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.

Image inclusion criteria：

When it is less than 6h (inclusive) from the onset of stroke to the completion of femoral artery puncture, patients should be examined by cranial CT or MR;
When it is more than 6h but less than 24h (inclusive) from the onset of stroke to the completion of femoral artery puncture, brain CT or MR should be performed and Aspects ≥6 points should be satisfied.(If immediate CT perfusion imaging or MR perfusion imaging is feasible, CTP or MRP is recommended to assist in the assessment of the infarct core, and Aspects ≥6 points shall also be satisfied);
DSA angiography showed acute intracranial arterial occlusion, including intracranial segment of internal carotid artery (C4-C7), middle cerebral artery (M1/M2), basilar artery and intracranial segment of vertebral artery (V4).

General exclusion criteria：

Neither MRI nor CT can be performed;
Hemorrhagic stroke or major ischemic stroke within 6 months before enrollment;
Severe persistent hypertension that cannot be controlled by venous hypotension, i.e., patients with SBP persistent >185mmHg and/or DBP persistent >110mmHg;
Suppose septic emboli or suspected bacterial endocarditis;
Renal failure, defined as: creatinine >3.0mg/dL(264 mol/L);
Blood glucose < 2.78mmol/L (50mg/dL) or >22.20mmol/L (400mg/dL);
decreased platelet count (< 40×109/L);
Known bleeding tendency, defect of coagulation factor, taking anticoagulants and INR > 3.0;
Pregnant or lactating women;
known to be severely allergic to contrast agents and known to be allergic to nickel materials;
The presence of diseases that may affect the assessment of neurological function (such as neurological diseases, mental diseases, etc.);
with heart, lung, liver function failure or other serious diseases to interventional surgery;
Participating in clinical trials of other drugs or devices;
Life expectancy less than 6 months;
Other conditions judged by the researcher to be unsuitable for inclusion.

Image exclusion criteria：

CT or MR imaging evidence of intracranial hemorrhage or known bleeding tendency;
CT/MR/DSA showed > occlusion (such as bilateral internal carotid artery occlusion at the same time, or anterior circulation and posterior circulation intracranial vessels occlusion at the same time, or internal carotid intracranial and extracranial segments occlusion at the same time);
Carotid artery dissection, carotid initial occlusion or arteritis;
The vascular circuitry was severe, and the intracranial thrombectomy stent was difficult to reach the target position.

Name	Affiliation	Role
Xinfeng Liu	General Hospital of Eastern Theater Command, PLA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ganzhou Municipal Hospital		Ganzhou			China
Ganzhou People's Hospital

PubMed Identifier	Type	Citation	Retractions
38507987	Derived	Huo S, Gao J, Lv Q, Xie M, Wang H, Zhang X, Xie Y, Wu M, Liu R, Liu X, Yuan K, Ye R. Trajectories of stroke severity and functional outcomes after endovascular treatment in ischemic stroke: A post hoc analysis of a randomized controlled trial. Clin Neurol Neurosurg. 2024 Apr;239:108248. doi: 10.1016/j.clineuro.2024.108248. Epub 2024 Mar 16.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 9, 2022	Dec 25, 2025

Arm/Group Information

ID	Title	Description
BG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
BG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name:Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000109 BG001109 BG002218

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000105 OG001103

Secondary

Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery

The Modified Rankin Scale is a global measure of functional disability ranging from 0 (no symptoms) to 6 (death), where lower scores indicate a better outcome. A score of 0-2 is commonly interpreted as a favorable functional outcome.

Posted

Number

participants

pre-procedure, and 90 days post-procedure

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts

Secondary

Vascular Recanalization Time

The time from femoral artery puncture to vascular recanalization or the end time of surgery for patients with no vascular recanalization. Vascular recanalization time = successful recanalization time - femoral artery puncture time

Posted

Mean

Standard Deviation

Min

intra-operative

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Secondary

The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points

The number of subjects exhibiting a >4-point decrease on the National Institutes of Health Stroke Scale (NIHSS; range 0-42, where higher scores indicate worse neurological deficit).

Posted

Number

participants

7 days post-procedure

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Secondary

Number of Devices Successfully Operated

Devices Successfully Operated defined devices completed conveying, releasing and retracting.

Posted

Number

device

intra-operative

Overall Number of Devices Analyzed

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Secondary

Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure

Symptomatic intracranial hemorrhage within 24 h, specifically intracranial hemorrhage (intracranial parenchymal hematoma, subarachnoid hemorrhage, and ventricular hemorrhage) accompanied by neurological deterioration

Posted

Number

participants

within 24 hours post-procedure

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts

Secondary

Number of Participants Who Died Within 90 Days

The count of all deaths from any cause occurring within 90 days post-procedure among participants who received the intracranial thrombectomy stent.

Posted

Number

participants

within 90 days

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Secondary

Number of Device Defects

The count of defects (e.g., device breakage, incorrect labeling) identified in the research devices during the clinical trial.

Posted

Number

device

intra-operative

Overall Number of Devices Analyzed

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Secondary

Number of Participants With Serious Adverse Events (SAE)

The count of participants who experienced at least one serious adverse event (SAE) after receiving thrombectomy with the intracranial thrombectomy device.

Posted

Number

participants

Within 90 days post-procedure

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Secondary

Number of Participants With Adverse Events (AE)

The count of participants who experienced at least one adverse event (AE) after receiving thrombectomy with the intracranial thrombectomy device.

Posted

Number

participants

Within 90 days post-procedure

ID	Title	Description
OG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
OG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Thrombectomy-SINOMED SR	Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow. Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset	23	109	33	109	103	109
EG001	Thrombectomy-Solitaire FR	Intracranial thrombectomy was performed with a control product（name: Solitaire FR） Intracranial thrombectomy stent: Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset	33	109	46	109	94	109

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
cerebral infarction	Nervous system disorders	Systematic Assessment	EG0001 affected109 at risk EG0019 affected109 at risk
Acute gastroenteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected109 at risk EG0010 affected109 at risk
Rapid atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 affected109 at risk EG0010 affected109 at risk
Gastrointestinal bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 affected109 at risk EG0010 affected109 at risk
Recurrent cardioembolism	Cardiac disorders	Systematic Assessment	EG0001 affected109 at risk EG0010 affected109 at risk
Formation of intramural hematoma at the origin of the left common carotid artery	Vascular disorders	Systematic Assessment	EG0001 affected109 at risk EG0010 affected109 at risk
Pulmonary infection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected109 at risk EG0013 affected109 at risk
Coronary heart disease	Cardiac disorders	Systematic Assessment	EG0000 affected109 at risk EG0012 affected109 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0000 affected109 at risk EG0013 affected109 at risk
Intracranial hemorrhage	Nervous system disorders	Systematic Assessment	EG0002 affected109 at risk EG0011 affected109 at risk
Patent foramen ovale	Cardiac disorders	Systematic Assessment	EG0000 affected109 at risk EG0011 affected109 at risk
Brain herniation	Injury, poisoning and procedural complications	Systematic Assessment	EG0006 affected109 at risk EG0014 affected109 at risk
Cerebral edema	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 affected109 at risk EG0015 affected109 at risk
Death	General disorders	Systematic Assessment	EG00016 affected109 at risk EG00117 affected109 at risk
Inferior vena cava filter placement	Surgical and medical procedures	Systematic Assessment	EG0000 affected109 at risk EG0011 affected109 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00028 affected109 at risk EG00126 affected109 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG00011 affected109 at risk EG0016 affected109 at risk
Hypoproteinemia	Metabolism and nutrition disorders	Systematic Assessment	EG00017 affected109 at risk EG00119 affected109 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG00019 affected109 at risk EG00120 affected109 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0006 affected109 at risk EG0015 affected109 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0009 affected109 at risk EG0019 affected109 at risk
Fever	General disorders	Systematic Assessment	EG0006 affected109 at risk EG0013 affected109 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0006 affected109 at risk EG0015 affected109 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00012 affected109 at risk EG00115 affected109 at risk
Hepatic failure	Hepatobiliary disorders	Systematic Assessment	EG0004 affected109 at risk EG0016 affected109 at risk
Infection	Infections and infestations	Systematic Assessment	EG00028 affected109 at risk EG00120 affected109 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00034 affected109 at risk EG00139 affected109 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected109 at risk EG0017 affected109 at risk
Hyperlactatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0004 affected109 at risk EG00111 affected109 at risk
Intracranial hemorrhage	Nervous system disorders	Systematic Assessment	EG00014 affected109 at risk EG00123 affected109 at risk
Cerebral edema	Nervous system disorders	Systematic Assessment	EG00011 affected109 at risk EG00113 affected109 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0007 affected109 at risk EG0016 affected109 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00018 affected109 at risk EG00118 affected109 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0006 affected109 at risk EG0017 affected109 at risk
Deep vein thrombosis (DVT) of the extremities	Vascular disorders	Systematic Assessment	EG00013 affected109 at risk EG0016 affected109 at risk
Gastrointestinal bleeding	Gastrointestinal disorders	Systematic Assessment	EG0007 affected109 at risk EG0016 affected109 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0003 affected109 at risk EG0017 affected109 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0007 affected109 at risk EG0012 affected109 at risk
Stress ulcer	Gastrointestinal disorders	Systematic Assessment	EG0006 affected109 at risk EG0013 affected109 at risk

ID	Term
D000083242	Ischemic Stroke
D001927	Brain Diseases
D002561	Cerebrovascular Disorders

ID	Term
D020521	Stroke
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases