Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic Stroke

NCT04973332 | Completed Results

• 1 other identifier: SINOMED SR
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 14

Brief Summary

A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke

Conditions

Ischemic Stroke, Acute; Brain Diseases; Cerebrovascular Disorders

Outcome Measures

Primary Outcomes (1)

• 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 (9)

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

  pre-procedure, and 90 days post-procedure

• Vascular Recanalization Time

  intra-operative

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

  7 days post-procedure

• Number of Devices Successfully Operated

  intra-operative

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

  within 24 hours post-procedure

Study Arms (2)

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

Intracranial thrombectomy stent DEVICE

Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Thrombectomy-SINOMED SR; Thrombectomy-Solitaire FR

Eligibility Criteria

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

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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;
• CT or MR imaging evidence of intracranial hemorrhage or known bleeding tendency;

Sponsors & Collaborators

• Sinomed Neurovita Technology Inc.: lead
• The General Hospital of Eastern Theater Command: collaborator

Study Sites (14)

Ganzhou Municipal Hospital

Ganzhou, China

Location

Ganzhou People's Hospital

Ganzhou, China

Location

Handan Central Hospital

Handan, China

Location

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hehui, China

Location

Jiangmen Wuyi Hospital of Traditional Chinese Medicine

Jiangmen, China

Location

Jinan Central Hospital

Jinan, China

Location

Meizhou People's Hospital

Meizhou, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

General Hospital of Eastern Theater Command, PLA

Nanjing, 210000, China

Location

Qingdao Center Hospital

Qingdao, China

Location

General Hospital of Northern Theater Command, PLA

Shenyang, China

Location

Taiyuan Central Hospital

Taiyuan, China

Location

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)

Wuhu, China

Location

Central Hospital of Xiang Tan city

Xiangtan, China

Location

Related Publications (1)

• 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.

  PMID: 38507987 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Brain Diseases; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Stroke; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ligang Xia
• Organization: Sinomed Neurovita Technology Inc.

xialigang@sinomed.com

18612448465

Study Officials

• Xinfeng Liu

  General Hospital of Eastern Theater Command, PLA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Prospective, multicenter, randomized controlled, non-infertility study

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 22, 2021
• Study Start: August 8, 2021
• Primary Completion: April 7, 2022
• Study Completion: June 24, 2022
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (14)