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

NCT ID: NCT05719688

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2024-05-24

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

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mechanical thrombectomy:Thrombectomy system

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.

Group Type: EXPERIMENTAL

Mechanical thrombectomy

Intervention Type: DEVICE

Treatment of ischemic stroke patients with Mechanical thrombectomy

Intracranial thrombectomy stent :Solitaire FR Revascularization Device

Subjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

Interventions

Mechanical thrombectomy

Treatment of ischemic stroke patients with Mechanical thrombectomy

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Hengruihongyuan Medical Technology Co. LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Xiangyang First People's Hospital

Xiangyang, Hubei, China

The first people's hospital of changzhou

Changzhou, Jiangsu, China

Zhangjiagang First People's Hospital

Suzhou, Jiangsu, China

The Second People's Hospital of Wuxi

Wuxi, Jiangsu, China

The affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Xianyang Hospital of Yan 'an University

Xianyang, Shanxi, 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

Countries

China

Other Identifiers

CRD01

Identifier Type: -

Identifier Source: org_study_id