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

NCT05496361 | Completed

• 1 other identifier: CTP-301
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

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.

Conditions

AIS; Acute Ischemic Stroke; Large Vessel Occlusion; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Times to revascularization（From groin puncture to final revascularization result）

  At immediate post-procedure

• NIHSS score at 24h, 7-day or discharge

  Within 24 hours，7-day or discharge post-procedure, whichever came first

• 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

Other Outcomes (4)

• Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours

  Within 24 hours post-procedure

• All causes of mortality at 90 days

  at 90 days post-procedure

• Occurrence of serious adverse events or adverse events related to device or procedure

  at 90 days post-procedure

Study Arms (2)

Tianyi Revascularization Device

EXPERIMENTAL

Device: Tianyi Revascularization Device

Solitaire FR Revascularization Device

ACTIVE COMPARATOR

Device: Solitaire FR Revascularization Device

Interventions

Tianyi Revascularization Device DEVICE

Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain

Tianyi Revascularization Device

Solitaire FR Revascularization Device DEVICE

Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain

Solitaire FR Revascularization Device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-85 years
• within 8 hours after symptom onset
• The results showed that the scores of ASPECTS ≥6, 0\<NIHSS\<30 , and mRS \<2 ;
• 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;
• Signed informed consent.

You may not qualify if:

• Patients with epileptic seizure during stroke;
• Patients with life expectancy less than 90 days;
• Patients with intracranial hemorrhage or subarachnoid hemorrhage on the same side in recent 3 months;
• Previous history of intracranial tumor, cerebral arteriovenous malformation or aneurysm without surgical treatment
• Patients with a history of cerebral infarction or myocardial infarction or uncontrolled serious infectious diseases (such as endocarditis or septicemia) in recent 3 months;
• Patients with gastrointestinal or urinary tract bleeding in the past three weeks;
• 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;
• Patients with serious mental history, heart, liver, lung and kidney failure or other serious diseases;
• Patients with active bleeding or known bleeding tendency (INR\>3.0 or platelet count\<40\*10\^9/L or APTT\>50 seconds);
• The blood glucose which could not be controlled by drugs was less than 2.7 mmol/L or more than 22.2 mmol/L;
• Patients with hypertension beyond the control of drugs (systolic blood pressure \>180 mmHg, or diastolic blood pressure \>105 mmHg);
• Females who are pregnant or in lactation;
• Patients who are known to be allergic or resistant to contrast agents, anesthetics, anticoagulants, antiplatelet drugs and nickel-titanium;
• Patients who have undergone major surgical operations in the past month;
• Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator);

Sponsors & Collaborators

• Suzhou Zenith Vascular Scitech Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: January 24, 2021
• Primary Completion: November 24, 2021
• Study Completion: July 20, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)