Clinical trial NCT05719688: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Sponsor class: INDUSTRY
First posted: 2023-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Immediate postoperative target vessel recanalization (mTICI≥2b) rate
timeFrame: Immediately after surgery
Secondary outcomes:
measure: The time from puncture to recanalization
timeFrame: immediately after surgery
measure: The number of thrombectomy
timeFrame: immediately after surgery
measure: the rate of successful vascular recirculation after the first thrombectomy
timeFrame: immediately after surgery
measure: NIHSS Score
timeFrame: 24hours and 7days after surgery
measure: Proportion of patients with an mRS Score of 0-2 at 90 days after surgery
timeFrame: 3 mouths after surgery
measure: Performance evaluation of the device
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang First People's Hospital
state: Hubei
city: Changzhou
country: China
facility: The first people's hospital of changzhou
state: Jiangsu
city: Suzhou
country: China
facility: Zhangjiagang First People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: The Second People's Hospital of Wuxi
state: Jiangsu
city: Xuzhou
country: China
facility: The affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Qingdao
country: China
facility: The affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Xianyang
country: China
facility: Xianyang Hospital of Yan 'an University
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
state: Zhejiang
Study officials:
References: