Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719688
• Other study ID #: CRD01
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Suzhou Hengruihongyuan Medical Technology Co. LTD
• Contact: jianmin liu, doctor
• Phone: 13901780638
• Email: liu118[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 18-85

2. Within 8 hours of the onset of stroke symptoms

3. There are clinical signs and symptoms consistent with acute ischemic stroke

4. 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)

5. 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. 6 points =NIHSS score < 30 points

7. Informed consent is signed by the patient or her legal guardian

Exclusion Criteria:

1. Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel

2. mRS = 2 before stroke

3. Pregnant Or Lactating Women

4. Hemorrhagic cerebrovascular history within 3 months

5. Refractory hypertension that cannot be controlled by medication (systolic blood pressure =185mmHg, or diastolic blood pressure =110mmHg)

6. Bleeding prone predisposition with severe coagulopathy, such as INR > 3.0 or platelet count < 40x10?9/L

7. Blood glucose at screening was < 2.8mmol/L or > 22 mmol/L

8. 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

9. Participate in other drug or device clinical trials within 28 days prior to screening visit

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Mechanical thrombectomy
Treatment of ischemic stroke patients with Mechanical thrombectomy

Locations

Country	Name	City	State
China	The first people's hospital of changzhou	Changzhou	Jiangsu
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jiaxing Second Hospital	Jiaxing	Zhejiang
China	Lishui Municipal Central Hospital	Lishui	Zhejiang
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Zhangjiagang First People's Hospital	Suzhou	Jiangsu
China	The Second People's Hospital of Wuxi	Wuxi	Jiangsu
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	Xiangyang First People's Hospital	Xiangyang	Hubei
China	Xianyang Hospital of Yan 'an University	Xianyang	Shanxi
China	The affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou	Fujian
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Hengruihongyuan Medical Technology Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after surgery
Secondary	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.	immediately after surgery
Secondary	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.	immediately after surgery
Secondary	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.	immediately after surgery
Secondary	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.	24hours and 7days after surgery
Secondary	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.	3 mouths after surgery
Secondary	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	immediately after surgery