The WEB®-IT China Clinical Study (WEB-IT China)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03207087|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Wide Neck Bifurcation Intracranial Aneurysms||Device: WEB Aneurysm Embolization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single group assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||WEB® Intrasaccular Therapy Study China Clinical Trial Protocol|
|Actual Study Start Date :||June 23, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: WEB Aneurysm Embolization Device
The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. Subjects will be screened for study eligibility after giving informed consent.
Device: WEB Aneurysm Embolization
Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques.
- Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis [ Time Frame: 12 month ]Proportion of complete (angiographic) aneurysm occlusion as assessed by Core Lab without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment.
- Primary Safety Endpoint: Proportion of death and major stroke [ Time Frame: 12 month ]Proportion of death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207087
|Contact: Liyun Zhangemail@example.com|
|Contact: Tom McCarthyfirstname.lastname@example.org|
|Xuanwu Hospital, Capital Medical University||Recruiting|
|Contact: Guilin 13901056074 email@example.com|
|Principal Investigator: Hongqi Zhang, MD|
|The Second affiliated Hospital of Zhejiang University School of Medicine||Not yet recruiting|
|Contact: Jing Xu 13805722695 firstname.lastname@example.org|
|Principal Investigator: Jianmin Zhang, MD|
|The General Hospital of Shenyang Military||Recruiting|
|Contact: Zhiqing Li 13898866708 email@example.com|
|Principal Investigator: Guobiao Liang, MD|
|Tangdu Hospital, the Fourth Military Medical University||Not yet recruiting|
|Contact: Jianping Deng 13909299990 firstname.lastname@example.org|
|Principal Investigator: Zhenwei Zhao|