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

Cerebrovascular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973332
• Other study ID #: SINOMED SR
• Status: Completed
• Phase: N/A
• Start date: August 8, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: September 2022
• Source: Sinomed Neurovita Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 24, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Cerebral Infarction
• Cerebrovascular Disorders
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Intracranial thrombectomy stent
Intracranial thrombectomy stents for ischemic stroke patients within 24 hours of symptom onset

Locations

Country	Name	City	State
China	General Hospital of Eastern Theater Command, PLA	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Sinomed Neurovita Technology Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of device defects	Defects of research devices during clinical trials, such as broken devices, incorrect labeling, etc	intra-operative
Secondary	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
Secondary	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