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NCT05719688Completed

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

Prospective, Multicenter, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

Source: ClinicalTrials.gov · Last updated 1 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
202 (actual)
First submitted
20 Nov 2022
Start date
16 Dec 2022
Primary completion date
31 Oct 2023
Lead sponsor
Suzhou Hengruihongyuan Medical Technology Co. LTD
Diseases
Stroke
NCT number
NCT05719688

What you commit to

  • Study type: Interventional
  • Participants enrolled: 202
  • From 16 Dec 2022 to the primary completion date, 31 Oct 2023
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel
  • mRS ≥ 2 before stroke
  • Refractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg)
  • 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

Lab values

  • 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

Other

  • Pregnant Or Lactating Women
  • Hemorrhagic cerebrovascular history within 3 months

Who the study is looking for

  • 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

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The First People's Hospital Of Changzhou
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ChangzhouChinaUnknown status
The First Affiliated Hospital of Dalian Medical University
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DalianChinaUnknown status
The First Affiliated Hospital of Jinan University
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GuangzhouChinaUnknown status
Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Jiaxing Second Hospital
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JiaxingChinaUnknown status
Lishui Municipal Central Hospital
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LishuiChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
Changhai Hospital of Shanghai
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ShanghaiChinaUnknown status
Zhangjiagang First People's Hospital
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SuzhouChinaUnknown status
The Second People's Hospital of Wuxi
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WuxiChinaUnknown status
Xiangyang First People's Hospital
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XiangyangChinaUnknown status
Xiangyang Central Hospital
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XiangyangChinaUnknown status
Xianyang Hospital of Yan'an University
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XianyangChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
Zhangzhou Municipal Hospital of Fujian Province
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ZhangzhouChinaUnknown status
Henan Provincial People's Hospital
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.