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
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital Of Changzhou Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| The First Affiliated Hospital of Jinan University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Jiaxing Second Hospital Coordinator of this site? Confirm its status | Jiaxing | China | Unknown status |
| Lishui Municipal Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Changhai Hospital of Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhangjiagang First People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| The Second People's Hospital of Wuxi Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Xiangyang First People's Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| Xianyang Hospital of Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Zhangzhou Municipal Hospital of Fujian Province Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.