New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
NCT ID: NCT02820779
Last Updated: 2016-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-06-30
2019-05-31
Brief Summary
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Detailed Description
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This study is a multi-center, prospective registration study.
Recruiting 100 specific patients to undergo a treatment with the WILLIS intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy.
Patients enrolled will undergo a one-year follow-up.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WILLIS
Patients undergo WILLIS intracranial covered stent interventional treatment
WILLIS
WILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. It can effectively shunt the blood flow and keep it off of the aneurysm wall.
Interventions
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WILLIS
WILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. It can effectively shunt the blood flow and keep it off of the aneurysm wall.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes;
* Target lesion vessel reference diameter 3.5-4.5mm;
* Investigators believe that the patient is suitable for the interventional therapy of WILLIS intracranial covered stent;
* Participate in the study voluntarily, accept follow up study and signed Informed Consent Form.
Exclusion Criteria
* No suitable vessel entrance, or diseased artery extremely tortuous;
* Coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment;
* Life expectancy \<1 year;
* Contraindications to heparin, aspirin, clopidogrel, anesthesia, X-ray or contrast agents;
* Mental disorder
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Harbin Medical University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Qilu Hospital of Shandong University
OTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Tang-Du Hospital
OTHER
West China Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Shaanxi Provincial People's Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
First Affiliated Hospital of Xinjiang Medical University
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Hongqi Zhang, MD
Cerebrovascular Expert Committee of Chinese Medical Doctor Association
Principal Investigators
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Locations
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Nanfang hospital, Southern Medical university
Guangzhou, Guangdong, China
The 2nd Affiliated Hospital of Harbin Medical university
Harbin, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical university
Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Qilu Hospital Of Shang Dong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
ShanXi Provincial People's Hospital
Taiyuan, Shanxi, China
Tangdu Hospital Fourth Military Medical University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang, China
Tongji Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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COVER 001
Identifier Type: -
Identifier Source: org_study_id
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