New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
- Conditions
- Carotid-Cavernous Sinus FistulaAneurysm, Intracranial
- Interventions
- Device: WILLIS
- Registration Number
- NCT02820779
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.
- Detailed Description
Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.WILLIS® intracranial stent graft system is indicated for the treatment of intracranial aneurysms.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Age over 18;
- 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.
- Existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion;
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WILLIS WILLIS Patients undergo WILLIS intracranial covered stent interventional treatment
- Primary Outcome Measures
Name Time Method 1-year treatment success rate 12 months Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%.
- Secondary Outcome Measures
Name Time Method X-ray exposure time 24 hours Target lesion treatment success rate Immediately after surgery Technically success rate of surgery immediately after surgery Technically success is defined as stent reach the target lesion and successfully released.
Target lesion was treated by interventional or surgical therapy once again 12 months Postoperative ipsilateral symptomatic stroke 30 days; 6 months; 12 months Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4.
Operative time through surgery completion Surgery-related complications or death 12 months All adverse events 12 months Various causes of death the perioperative period to 12 months Recurrence of target lesion 12 months Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture 12 months Occurs intracranial ischemic stroke that caused by thrombus 12 months Device-related serious adverse events 12 months Target lesion appears stenosis 12 months after surgery 12 months Stenosis is defined as target stenosis ≥50%
NIHSS 30 days; 6 months; 12 months Modified Rankin Scale 30 days; 6 months; 12 months
Trial Locations
- Locations (11)
Tangdu Hospital Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
The 2nd Affiliated Hospital of Harbin Medical university
🇨🇳Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Tongji Hospital
🇨🇳Shanghai, China
Qilu Hospital Of Shang Dong University
🇨🇳Jinan, Shandong, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Nanfang hospital, Southern Medical university
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital Of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital of Harbin Medical university
🇨🇳Harbin, Heilongjiang, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
ShanXi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China