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

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke

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

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Disorders; Brain Diseases; Ischemic Stroke, Acute
• Intervention / Treatment: Device: Intracranial thrombectomy stent

Detailed Description

This is a multicenter, prospective, randomized, 1:1, controlled trial with blinded outcome assessment assessing non-inferiority of SINOMED SR compared to Solitaire FR. The trial aims to randomize 220 patients 1:1 to receive SINOMED SR or Solitaire FR.The primary outcome is the Success rate of immediate recanalization.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanjing, China, 210000
    • General Hospital of Eastern Theater Command, PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General inclusion criteria：

1. 18 years old or more;
2. NIHSS≥6 during randomization;
3. Pre-onset MRS < 2;
4. Acute ischemic stroke was diagnosed;
5. 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;
6. The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.

Image inclusion criteria：

1. 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;
2. 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);
3. 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：

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

Image exclusion criteria：

1. CT or MR imaging evidence of intracranial hemorrhage or known bleeding tendency;
2. 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);
3. Carotid artery dissection, carotid initial occlusion or arteritis;
4. The vascular circuitry was severe, and the intracranial thrombectomy stent was difficult to reach the target position.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Intracranial thrombectomy stent; Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset
Active Comparator: Thrombectomy-Solitaire FR; Intracranial thrombectomy was performed with a control product（name:Solitaire FR）	Device: Intracranial thrombectomy stent; Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mRS 0-2 ratio	The ratio of mRS 0-2 points = the number of subjects with mRS 0-2 points 90 days after surgery/the number of subjects receiving thrombectomy by intracranial thrombectomy device ×100%	pre-procedure, and 90 days post-procedure
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	intra-operative
The NIHSS score decreased the rate of subjects with > 4 points	The ratio of subjects with NIHSS score decreased > 4 points = the number of subjects with NIHSS score decreased > 4 points/the number of subjects with thrombotic stent thrombectomy ×100% in this group	pre-procedure, 24 hours and 7 days post-procedure
Success rate of instrument operation	Device operation success = the number of devices completed conveying, releasing and retracting in the group/the number of all test devices used in the group ×100%	intra-operative
The incidence of 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 (NIHSS score increased by ≥4 points compared with preoperative)	within 24 hours post-procedure
Mortality within 90 days	All-cause mortality = the number of deaths in this group/the number of subjects receiving intracranial thrombectomy stent for thrombectomy in this group ×100%	within 90 days
Incidence of device defects	Defects of research devices during clinical trials, such as broken devices, incorrect labeling, etc	intra-operative
Incidence of SAE (serious adverse events)	Incidence of SAE = number of subjects with SAE/number of subjects receiving thrombectomy with intracranial thrombectomy device ×100%	intra-operative, 24 hours, 7 days and 90 days post-procedure
Incidence of AE (adverse events)	Incidence of AE = number of subjects with AE/number of subjects receiving thrombectomy with intracranial thrombectomy device ×100%	intra-operative, 24 hours, 7 days and 90 days post-procedure

Collaborators and Investigators

• Sponsor: Sinomed Neurovita Technology Inc.
• Investigators: Principal Investigator: Xinfeng Liu, General Hospital of Eastern Theater Command, PLA

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2021
• Primary Completion (Actual): April 7, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Brain Diseases; Cerebral Infarction; Cerebrovascular Disorders
• Other Study ID Numbers: SINOMED SR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No