Back to resultsA Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke
Primary Purpose
AIS, Acute Ischemic Stroke, Large Vessel Occlusion
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tianyi Revascularization Device
Solitaire FR Revascularization Device
Sponsored by
About this trial
This is an interventional treatment trial for AIS
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
Clinical exclusion criteria:
- 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- Patients who have participated in clinical trials of other drugs or devices and have not been withdrawn from the group within the first one months of the screening period of this trial;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;
- 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
- Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator);
- ASPECTS <6 points on head CT;
- Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion;
- DSA showed that bilateral carotid system was occluded at the same time;
- DSA showed (or highly suspected) carotid dissection or arteritis;
- DSA showed that the vascular route was tortuous, and the device was difficult to reach the target position or recover;
- Subjects who are not eligible for inclusion after imaging review in the group judged by researchers.
Sites / Locations
- Shanghai Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tianyi Revascularization Device
Solitaire FR Revascularization Device
Arm Description
Outcomes
Primary Outcome Measures
Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
Secondary Outcome Measures
Times to revascularization（From groin puncture to final revascularization result）
NIHSS score at 24h, 7-day or discharge
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2
Device Technical Success
Full Information
NCT ID
NCT05496361
First Posted
August 9, 2022
Last Updated
August 10, 2022
Sponsor
Suzhou Zenith Vascular Scitech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05496361
Brief Title
A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke
Official Title
A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2021 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zenith Vascular Scitech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIS, Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tianyi Revascularization Device
Arm Type
Experimental
Arm Title
Solitaire FR Revascularization Device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Tianyi Revascularization Device
Intervention Description
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Intervention Type
Device
Intervention Name(s)
Solitaire FR Revascularization Device
Intervention Description
Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain
Primary Outcome Measure Information:
Title
Revascularization assessed by digital subtraction angiography of the occluded target vessel to mTICI 2b or 3 at immediate post-procedure
Time Frame
At immediate post-procedure
Secondary Outcome Measure Information:
Title
Times to revascularization（From groin puncture to final revascularization result）
Time Frame
At immediate post-procedure
Title
NIHSS score at 24h, 7-day or discharge
Time Frame
Within 24 hours，7-day or discharge post-procedure, whichever came first
Title
Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2
Time Frame
at 90 days post-procedure
Title
Device Technical Success
Time Frame
At immediate post-procedure
Other Pre-specified Outcome Measures:
Title
Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Time Frame
Within 24 hours post-procedure
Title
All causes of mortality at 90 days
Time Frame
at 90 days post-procedure
Title
Occurrence of serious adverse events or adverse events related to device or procedure
Time Frame
at 90 days post-procedure
Title
Occurrence of device defect
Time Frame
at 90 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Clinical exclusion criteria:
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;
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
Patients with intracerebral hemorrhage confirmed by CT (except for microbleeds. At the discretion of each Investigator);
ASPECTS <6 points on head CT;
Patients with common carotid artery occlusion who are known or suspected to be chronic occlusion;
DSA showed that bilateral carotid system was occluded at the same time;
DSA showed (or highly suspected) carotid dissection or arteritis;
DSA showed that the vascular route was tortuous, and the device was difficult to reach the target position or recover;
Subjects who are not eligible for inclusion after imaging review in the group judged by researchers.
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke
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