Back to resultsEvaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
Primary Purpose
Acute Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mechanical thrombectomy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Age 18-85 Within 8 hours of the onset of stroke symptoms There are clinical signs and symptoms consistent with acute ischemic stroke Imaging examination excluded intracranial hemorrhage, and there were no imaging changes of early large cerebral infarction (large infarction was defined as the aspect score of CT or DWI image < 6, infarct volume ≥70ml or infarct area > 1/3MCA) Patients with imaging evidence of stroke caused by occlusion of the internal carotid artery (intracranial segment) or the M1/M2 segment of the middle cerebral artery or the A1/A2 segment of the anterior cerebral artery without clear contraindications 6 points ≤NIHSS score < 30 points Informed consent is signed by the patient or her legal guardian Exclusion Criteria: Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel mRS ≥ 2 before stroke Pregnant Or Lactating Women Hemorrhagic cerebrovascular history within 3 months Refractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg) Bleeding prone predisposition with severe coagulopathy, such as INR > 3.0 or platelet count < 40x10∧9/L Blood glucose at screening was < 2.8mmol/L or > 22 mmol/L Patients with any of the following exclusion criteria were not eligible to participate in this study Preoperative CT or MRI showed bleeding symptoms CT or MRI shows intracranial mass or intracranial tumor requiring surgical treatment Angiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid artery Angiography revealed simultaneous acute obstruction of both carotid systems Participate in other drug or device clinical trials within 28 days prior to screening visit
Sites / Locations
- Zhangzhou Municipal Hospital of Fujian Province
- Guangdong Provincial People's Hospital
- The First Affiliated Hospital of Jinan University
- Henan Provincial People's Hospital
- Xiangyang Central Hospital
- Xiangyang First People's Hospital
- The first people's hospital of changzhou
- Zhangjiagang First People's Hospital
- The Second People's Hospital of WuxiRecruiting
- The affiliated Hospital of Xuzhou Medical University
- The Second Affiliated Hospital of Nanchang University
- The First Affiliated Hospital of Dalian Medical University
- The affiliated Hospital of Qingdao University
- Changhai Hospital of Shanghai
- Xianyang Hospital of Yan 'an University
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Jiaxing Second Hospital
- Lishui Municipal Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mechanical thrombectomy:Thrombectomy system
Intracranial thrombectomy stent :Solitaire FR Revascularization Device
Arm Description
Subjects will be treated with Thrombectomy system,Thrombectomy system is an intraarterial thrombectomy removal device that can be re-inserted into the sheath to restore blood flow by removing blood clots in occluded vessels.
Subjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular
Outcomes
Primary Outcome Measures
Immediate postoperative target vessel recanalization (mTICI≥2b) rate
According to 《the recommendations of the Chinese Guidelines for Stroke Prevention and Treatment》 , the therapeutic goal of mechanical thrombectomy is to achieve reperfusion of mTICI≥2b, so as to achieve the best possible functional outcome for patients. Therefore, we selected immediate postoperative target vessel recanalization (mTICI≥2b) rate as the primary efficacy endpoint.
Secondary Outcome Measures
The time from puncture to recanalization
The time from onset to recanalization will affect the prognosis of patients, and shorter recanalization time will bring better prognostic effect. Therefore, we chose the time from puncture to recanalization to compare the opening efficiency of the two groups of instruments.
The number of thrombectomy
The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the number of thrombectomy as indicators to evaluate the efficiency of the opening of the instrument.
the rate of successful vascular recirculation after the first thrombectomy
The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the rate of successful vascular recirculation after the first thrombectomy as indicators to evaluate the efficiency of the opening of the instrument.
NIHSS Score
The Assessment of Neurological Deficits (NIHSS score) is a well-established and widely accepted scale for evaluating neurological deficits in stroke patients. Neurological function evaluation (NIHSS score) at one day after endovascular therapy is helpful to predict clinical outcome at 90 days after surgery. A score of 3 is usually considered as the limit. A score of 3 or less indicates a mild stroke, a score of 3-10 is a moderate stroke, and a score of more than 10 is a severe stroke.
Proportion of patients with an mRS Score of 0-2 at 90 days after surgery
MRS Score, also known as modified Rankin score scale, is a scale used to evaluate the recovery state of neurological function in stroke patients. There are seven levels, level 0: completely asymptomatic. Level 1: Despite symptoms, the patient has no apparent disability and can perform all regular work and activities. Level 2: Mildly disabled, unable to perform all work and activities, but able to handle personal matters without assistance from others. Level 3: moderately disabled, requiring assistance, to walking without assistance. Level 4: Severely disabled, unable to walk without assistance, unable to care for their own needs. Level 5: Severely disabled, bedridden, incontinent, in need of constant care, and in need of multiple round-the-clock attention. Level 6: Dead .The proportion of subjects with mRS Score of 0-2 at 90 days after surgery was selected as the basis for judging the prognosis of subjects.
Performance evaluation of the device
Device performance evaluation can help to evaluate the maneuverability of research devices in clinical application.Including the ability of the instrument to reach the lesion, the ability of the instrument to release and deploy smoothly, and the difficulty of the instrument to withdraw
Full Information
NCT ID
NCT05719688
First Posted
November 20, 2022
Last Updated
January 30, 2023
Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
1. Study Identification
Unique Protocol Identification Number
NCT05719688
Brief Title
Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
Official Title
Prospective, Multicenter, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the experiment, 200 subjects were selected and randomly divided into the experimental group and the control group 1:1. According to the information of the group, corresponding devices were used to receive endovascular therapy and the results were evaluated.
Detailed Description
Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the trial, 200 subjects with acute ischemic stroke who met the inclusion criteria and did not meet any exclusion criteria were randomly divided into the test group and the control group at 1:1, and received endovascular therapy with corresponding instruments according to the information of the group and evaluated the results
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mechanical thrombectomy:Thrombectomy system
Arm Type
Experimental
Arm Description
Subjects will be treated with Thrombectomy system,Thrombectomy system is an intraarterial thrombectomy removal device that can be re-inserted into the sheath to restore blood flow by removing blood clots in occluded vessels.
Arm Title
Intracranial thrombectomy stent :Solitaire FR Revascularization Device
Arm Type
Active Comparator
Arm Description
Subjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular
Intervention Type
Device
Intervention Name(s)
Mechanical thrombectomy
Intervention Description
Treatment of ischemic stroke patients with Mechanical thrombectomy
Primary Outcome Measure Information:
Title
Immediate postoperative target vessel recanalization (mTICI≥2b) rate
Description
According to 《the recommendations of the Chinese Guidelines for Stroke Prevention and Treatment》 , the therapeutic goal of mechanical thrombectomy is to achieve reperfusion of mTICI≥2b, so as to achieve the best possible functional outcome for patients. Therefore, we selected immediate postoperative target vessel recanalization (mTICI≥2b) rate as the primary efficacy endpoint.
Time Frame
Immediately after surgery
Secondary Outcome Measure Information:
Title
The time from puncture to recanalization
Description
The time from onset to recanalization will affect the prognosis of patients, and shorter recanalization time will bring better prognostic effect. Therefore, we chose the time from puncture to recanalization to compare the opening efficiency of the two groups of instruments.
Time Frame
immediately after surgery
Title
The number of thrombectomy
Description
The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the number of thrombectomy as indicators to evaluate the efficiency of the opening of the instrument.
Time Frame
immediately after surgery
Title
the rate of successful vascular recirculation after the first thrombectomy
Description
The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the rate of successful vascular recirculation after the first thrombectomy as indicators to evaluate the efficiency of the opening of the instrument.
Time Frame
immediately after surgery
Title
NIHSS Score
Description
The Assessment of Neurological Deficits (NIHSS score) is a well-established and widely accepted scale for evaluating neurological deficits in stroke patients. Neurological function evaluation (NIHSS score) at one day after endovascular therapy is helpful to predict clinical outcome at 90 days after surgery. A score of 3 is usually considered as the limit. A score of 3 or less indicates a mild stroke, a score of 3-10 is a moderate stroke, and a score of more than 10 is a severe stroke.
Time Frame
24hours and 7days after surgery
Title
Proportion of patients with an mRS Score of 0-2 at 90 days after surgery
Description
MRS Score, also known as modified Rankin score scale, is a scale used to evaluate the recovery state of neurological function in stroke patients. There are seven levels, level 0: completely asymptomatic. Level 1: Despite symptoms, the patient has no apparent disability and can perform all regular work and activities. Level 2: Mildly disabled, unable to perform all work and activities, but able to handle personal matters without assistance from others. Level 3: moderately disabled, requiring assistance, to walking without assistance. Level 4: Severely disabled, unable to walk without assistance, unable to care for their own needs. Level 5: Severely disabled, bedridden, incontinent, in need of constant care, and in need of multiple round-the-clock attention. Level 6: Dead .The proportion of subjects with mRS Score of 0-2 at 90 days after surgery was selected as the basis for judging the prognosis of subjects.
Time Frame
3 mouths after surgery
Title
Performance evaluation of the device
Description
Device performance evaluation can help to evaluate the maneuverability of research devices in clinical application.Including the ability of the instrument to reach the lesion, the ability of the instrument to release and deploy smoothly, and the difficulty of the instrument to withdraw
Time Frame
immediately after surgery
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:
Age 18-85
Within 8 hours of the onset of stroke symptoms
There are clinical signs and symptoms consistent with acute ischemic stroke
Imaging examination excluded intracranial hemorrhage, and there were no imaging changes of early large cerebral infarction (large infarction was defined as the aspect score of CT or DWI image < 6, infarct volume ≥70ml or infarct area > 1/3MCA)
Patients with imaging evidence of stroke caused by occlusion of the internal carotid artery (intracranial segment) or the M1/M2 segment of the middle cerebral artery or the A1/A2 segment of the anterior cerebral artery without clear contraindications
6 points ≤NIHSS score < 30 points
Informed consent is signed by the patient or her legal guardian
Exclusion Criteria:
Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel
mRS ≥ 2 before stroke
Pregnant Or Lactating Women
Hemorrhagic cerebrovascular history within 3 months
Refractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg)
Bleeding prone predisposition with severe coagulopathy, such as INR > 3.0 or platelet count < 40x10∧9/L
Blood glucose at screening was < 2.8mmol/L or > 22 mmol/L
Patients with any of the following exclusion criteria were not eligible to participate in this study
Preoperative CT or MRI showed bleeding symptoms
CT or MRI shows intracranial mass or intracranial tumor requiring surgical treatment
Angiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid artery
Angiography revealed simultaneous acute obstruction of both carotid systems
Participate in other drug or device clinical trials within 28 days prior to screening visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianmin liu, doctor
Phone
13901780638
Email
liu118@vip.163.com
Facility Information:
Facility Name
Zhangzhou Municipal Hospital of Fujian Province
City
Zhangzhou
State/Province
Fujian
ZIP/Postal Code
363000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhuo Chen
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengbo Dai
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lian Huang
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianxiao Liu
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liying Chang
Facility Name
Xiangyang First People's Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiyang Zhou
Facility Name
The first people's hospital of changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Peng
Facility Name
Zhangjiagang First People's Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuyi Wu
Facility Name
The Second People's Hospital of Wuxi
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojie Lu
Facility Name
The affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbo Cheng
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianglong Tu
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Wang
Facility Name
The affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Zhang
Facility Name
Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Facility Name
Xianyang Hospital of Yan 'an University
City
Xianyang
State/Province
Shanxi
ZIP/Postal Code
712000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Song
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao Chen
Facility Name
Jiaxing Second Hospital
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Liu
Facility Name
Lishui Municipal Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323499
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiansong Ji
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
We'll reach out to this number within 24 hrs