A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: AIS; Acute Ischemic Stroke; Thrombectomy; Large Vessel Occlusion
• Interventions: Device: Tianyi Revascularization Device; Device: Solitaire FR Revascularization Device

• Registration Number: NCT05496361
• Lead Sponsor: Suzhou Zenith Vascular Scitech Co., Ltd.

Brief Summary

This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.

Detailed Description

This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.

Study Timeline

• Study Start: 2021-01-24
• Primary Completion: 2021-11-24
• Study Completion: 2022-07-20
• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-10
• Last Update Submitted: 2022-08-10
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

1. aged 18-85 years
2. within 8 hours after symptom onset
3. The results showed that the scores of ASPECTS ≥6, 0<NIHSS<30 , and mRS <2 ;
4. caused by a large vessel occlusion of the anterior circulation (internal carotid artery or the M1 and M2 segments of MCA and the A1 and A2 segments) cerebral artery confirmed by DSA;
5. Signed informed consent.

Exclusion Criteria

Clinical exclusion criteria:

1. Patients with epileptic seizure during stroke;
2. Patients with life expectancy less than 90 days;
3. Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months;
4. Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment
5. Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months;
6. Patients with gastrointestinal or urinary tract bleeding in the past three weeks;
7. Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn from the group within the first one months of the screening period of this trial;
8. Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases;
9. Patients with active bleeding or known bleeding tendency (INR>3.0 or platelet count<40*10^9/L or APTT>50 seconds);
10. The blood glucose which could not be controlled by drugs was less than 2.7 mmol/L or more than 22.2 mmol/L;
11. Patients with hypertension beyond the control of drugs (systolic blood pressure >180 mmHg, or diastolic blood pressure >105 mmHg);
12. Females who are pregnant or in lactation;
13. Patients who are known to be allergic or resistant to contrast agents, anesthetics, anticoagulants, antiplatelet drugs and nickel-titanium;
14. Patients who have undergone major surgical operations in the past month;
15. Other cases with unknown onset time or unsuitable for inclusion in the group judged by researchers;other conditions not suitable for inclusion judged by the researcher;

Imaging exclusion criteria

1. Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator);
2. ASPECTS <6 points on head CT;
3. Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion;
4. DSA showed that bilateral carotid system was occluded at the same time;
5. DSA showed (or highly suspected) carotid dissection or arteritis;
6. DSA showed that the vascular route was tortuous, and the device was difficult to reach the target position or recover;
7. Subjects who are not eligible for inclusion after imaging review in the group judged by researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tianyi Revascularization Device	Tianyi Revascularization Device	-
Solitaire FR Revascularization Device	Solitaire FR Revascularization Device	-

Primary Outcome Measures

Name	Time	Method
Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure	At immediate post-procedure

Secondary Outcome Measures

Name	Time	Method
NIHSS score at 24h, 7-day or discharge	Within 24 hours，7-day or discharge post-procedure, whichever came first
Times to revascularization（From groin puncture to final revascularization result）	At immediate post-procedure
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2	at 90 days post-procedure
Device Technical Success	At immediate post-procedure

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, China