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

NCT05719688 | Completed

• 1 other identifier: CRD01
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 18

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The time from puncture to recanalization

  immediately after surgery

• The number of thrombectomy

  immediately after surgery

• the rate of successful vascular recirculation after the first thrombectomy

  immediately after surgery

• NIHSS Score

  24hours and 7days after surgery

• Proportion of patients with an mRS Score of 0-2 at 90 days after surgery

  3 mouths after surgery

Study Arms (2)

Mechanical thrombectomy:Thrombectomy system

EXPERIMENTAL

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.

Device: Mechanical thrombectomy

Intracranial thrombectomy stent :Solitaire FR Revascularization Device

ACTIVE COMPARATOR

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

Interventions

Mechanical thrombectomy DEVICE

Treatment of ischemic stroke patients with Mechanical thrombectomy

Mechanical thrombectomy:Thrombectomy system

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• points ≤NIHSS score \< 30 points
• Informed consent is signed by the patient or her legal guardian

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Suzhou Hengruihongyuan Medical Technology Co. LTD: lead

Study Sites (18)

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, 363000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510000, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 441100, China

Location

Xiangyang First People's Hospital

Xiangyang, Hubei, 441100, China

Location

The first people's hospital of changzhou

Changzhou, Jiangsu, 213000, China

Location

Zhangjiagang First People's Hospital

Suzhou, Jiangsu, 215000, China

Location

The Second People's Hospital of Wuxi

Wuxi, Jiangsu, 214000, China

Location

The affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

The affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200000, China

Location

Xianyang Hospital of Yan 'an University

Xianyang, Shanxi, 712000, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Jiaxing Second Hospital

Jiaxing, Zhejiang, 314000, China

Location

Lishui Municipal Central Hospital

Lishui, Zhejiang, 323499, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: February 9, 2023
• Study Start: December 16, 2022
• Primary Completion: October 31, 2023
• Study Completion: May 24, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)