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The WEB®-IT China Clinical Study (WEB-IT China)

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ClinicalTrials.gov Identifier: NCT03207087
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Sequent Medical, Inc

Brief Summary:
This trial is a prospective, multicenter, single-arm Objective Performance Criteria controlled confirmatory study. It is for evaluating safety and effectiveness of the WEB Aneurysm Embolization System when treating wide neck bifurcation aneurysms (WNBN).The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.

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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient whose age ≥ 18 and ≤75 years old
  • Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
  • Patient must sign and date IRB/EC approved written informed consent prior to initiate of any study procedures

Exclusion Criteria:

  • Patient has an IA with characteristics unsuitable for endovascular treatment
  • Patient has stroke-in-evolution within the prior 60-days
  • Patient has had an SAH(subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
  • Patient's index IA was previously treated
  • Patient is pregnant

Information from the National Library of Medicine

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


Contacts
Contact: Liyun Zhang 714-602-0192 lena.zhang@microvention.com
Contact: Tom McCarthy 949-923-9700 tom.mccarthy@microvention.com

Locations
China
Xuanwu Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Guilin    13901056074    hqzh@vip.163.com   
Principal Investigator: Hongqi Zhang, MD         
The Second affiliated Hospital of Zhejiang University School of Medicine Not yet recruiting
Hangzhou, China
Contact: Jing Xu    13805722695    z2sjwk@sina.com   
Principal Investigator: Jianmin Zhang, MD         
The General Hospital of Shenyang Military Recruiting
Shenyang, China
Contact: Zhiqing Li    13898866708    liangguobiao6708@163.com   
Principal Investigator: Guobiao Liang, MD         
Tangdu Hospital, the Fourth Military Medical University Not yet recruiting
Xi'an, China
Contact: Jianping Deng    13909299990    zhaozhenwei_dr@163.com   
Principal Investigator: Zhenwei Zhao         
Sponsors and Collaborators
Sequent Medical, Inc

Responsible Party: Sequent Medical, Inc
ClinicalTrials.gov Identifier: NCT03207087     History of Changes
Other Study ID Numbers: CP-16-001
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases