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注册号: Registration number: |
ChiCTR2500108540 |
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最近更新日期: Date of Last Refreshed on: |
2025-09-01 16:50:41 |
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注册时间: Date of Registration: |
2025-09-01 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
近端血流控制装置用于急性大血管闭塞血管内治疗的多中心、随机、开放标签、盲法终点评估临床研究 |
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Public title: |
Efficacy and safety of proximal blood flow arrest during endovascular thrombectomy, A multicenter, randomized, open-label, blind-endpoint clinical trial. |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
近端血流控制装置用于急性大血管闭塞血管内治疗的多中心、随机、开放标签、盲法终点评估临床研究(PEREFECT试验) |
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Scientific title: |
A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation Clinical Study of Proximal Blood Flow Control Devices for the Endovascular Treatment of Acute Large Vessel Occlusion (PEREFECT Trial) |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
资文杰 |
研究负责人: |
郑鹏 |
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Applicant: |
Zi Wenjie |
Study leader: |
Zheng Peng |
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申请注册联系人电话: Applicant telephone: |
+86 185 2303 3816 |
研究负责人电话:
Study leader's |
+86 185 8101 0769 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
ziwenjie@126.com |
研究负责人电子邮件: Study leader's E-mail: |
282971157@qq.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
重庆市沙坪坝区新桥正街183号 |
研究负责人通讯地址: |
重庆市渝中区袁家岗友谊路1号 |
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Applicant address: |
No. 183, Xinqiao Main Street, Shapingba District, Chongqing |
Study leader's address: |
No. 1, Yuanjiagang Youyi Road, Yuzhong District, Chongqing |
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申请注册联系人邮政编码: Applicant postcode: |
400037 |
研究负责人邮政编码: Study leader's postcode: |
400016 |
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申请人所在单位: |
陆军军医大学第二附属医院(新桥医院) |
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Applicant's institution: |
The Second Affiliated Hospital of the Army Medical University (Xinqiao Hospital) |
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研究负责人所在单位: |
重庆医科大学附属第一医院 |
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Affiliation of the Leader: |
The First Affiliated Hospital of Chongqing Medical University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2025年科研伦审(ZZ2025-292-01) |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
重庆医科大学附属第一医院伦理委员会 |
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Name of the ethic committee: |
Medical Research Ethics Review Committee of the First Affiliated Hospital of Chongqing Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-04-21 00:00:00 | ||
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伦理委员会联系人: |
严青 |
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Contact Name of the ethic committee: |
Yan Qing |
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伦理委员会联系地址: |
重庆市渝中区袁家岗友谊路1号 |
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Contact Address of the ethic committee: |
No. 1, Yuanjiagang Youyi Road, Yuzhong District, Chongqing |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 23 8901 1876 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
444158752@qq.com |
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研究实施负责(组长)单位: |
重庆医科大学附属第一医院 |
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Primary sponsor: |
The First Affiliated Hospital of Chongqing Medical University |
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研究实施负责(组长)单位地址: |
重庆市渝中区袁家岗友谊路1号 |
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Primary sponsor's address: |
No. 1, Yuanjiagang Youyi Road, Yuzhong District, Chongqing |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自选课题 |
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Source(s) of funding: |
Self funded |
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研究疾病: |
急性缺血性脑卒中 |
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Target disease: |
Acute Ischemic Stroke |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
旨在探讨急性前循环大血管闭塞性卒中接受血管内治疗采用近端血流控制装置的有效性及安全性,为此类患者提供高级别循证医学证据。 |
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Objectives of Study: |
This study aims to explore the efficacy and safety of proximal blood flow arrest in endovascular treatment for patients with acute anterior circulation large vessel occlusive stroke, and to provide high - level evidence - based medical evidence for such patients. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.经头颅 CT 或 MRI 证实颅内出血; 2.同侧颈内动脉颅外段严重狭窄(>90%)或串联闭塞; 3.同侧颈动脉之前植入的支架; 4.同侧颈动脉的夹层; 5.正在参加其他影响本研究的药物或器械临床试验; 6.发病前 mRS 评分>=2 分; 7.妊娠或哺乳期妇女; 8.对造影剂过敏; 9.血糖<2.8mmol/L(50mg/dl)或>22.2mmol/L(400mg/dl); 10.收缩压>185mmHg 或舒张压>110mmHg,且口服降压药物无法控制; 11.遗传学或获得性出血体质,抗凝因子缺乏;或已口服抗凝药且INR>1.7; 12.入院血小板计数小于70x 10^9/L; 13.动脉迂曲致取栓装置无法到达目标血管; 14.近 1 个月有出血史(胃肠道及尿路出血); 15.慢性血液透析及严重肾功能不全(肾小球滤过率<30ml/min 或血肌酐>220μmol/L(2.5mg/dl))患者; 16.任何疾病晚期致预期寿命<6 个月; 17.预期不能完成随访; 18.颅内动脉瘤、动静脉畸形; 19.影像学上具有占位效应的脑肿瘤; 20.黄斑水肿; |
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Exclusion criteria: |
1. Intracranial hemorrhage confirmed by CT or MRI of the head; 2. Severe stenosis (>90%) or tandem occlusion of the lateral cranial segment of the ipsilateral internal carotid artery; 3. Stent previously implanted in the ipsilateral carotid artery; 4. Dissection of the ipsilateral carotid artery; 5. Participating in other drug or device clinical trials affecting this study; 6. Pre-onset mRS score >=2 points; 7. Pregnant or lactating women; 8. Allergy to contrast agents; 9. Blood glucose < 2.8mmol/L (50mg/dl) or >22.2mmol/L (400mg/dl); 10. Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg, and oral antihypertensive drugs cannot be controlled; 11. Genetic or acquired bleeding constitution, lack of anticoagulant factors; or have taken oral anticoagulants with INR>1.7; 12. Platelet count less than 70x 10^9/L; 13. Arterial tortuosity causes thrombectomy device to fail to reach the target blood vessel; 14. History of bleeding (gastrointestinal and urinary tract bleeding) in the past 1 month; 15. Patients with chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30ml/min or serum creatinine > 220μmol/L (2.5mg/dl)); 16. Life expectancy < 6 months due to advanced disease; 17. Expected to be unable to complete follow-up; 18. Intracranial aneurysm, arteriovenous malformation; 19. Brain tumors with mass effect on imaging; 20. Macular edema; |
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研究实施时间: Study execute time: |
从 From 2025-01-01 00:00:00至 To 2027-08-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-09-01 00:00:00 至 To 2026-11-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
患者按照1:1 比例被随机分成两组。本试验采用分层隐匿区组长度的随机化的方法进行随机化分组,按照分中心进行分层,区组长度包括4、6 及8,患者以1:1 比例产生随机分组序列。各分中心研究者在患者签署知情同意书后报告组长单位研究者,后者通过随机化软件实现随机化分组。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Patients are randomly assigned to two groups at a 1:1 ratio. This trial uses a stratified concealed randomization method with variable block lengths for grouping, stratified by participating centers. Block lengths include 4, 6, and 8, and randomization sequences are generated with a 1:1 ratio. After patients sign the informed consent form, researchers at each participating center report to the researchers at the leading center, who then perform randomization via randomization software. |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
本试验对终点事件评估者及数据分析者设盲。 |
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Blinding: |
The trial blinded the endpoint event assessors and data analysts. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
CRF |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
CRF |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |