New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

Conditions
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Aneurysm, Intracranial, Carotid-Cavernous Sinus Fistula

Intervention / Treatment
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* Device: WILLIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WILLIS<br>Patients undergo WILLIS intracranial covered stent interventional treatment | Device: WILLIS<br>* 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.<br>* Other names: WILLIS® intracranial stent graft system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year treatment success rate | Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technically success rate of surgery | Technically success is defined as stent reach the target lesion and successfully released. | immediately after surgery | 
| Target lesion treatment success rate |  | Immediately after surgery | 
| X-ray exposure time |  | 24 hours | 
| Operative time |  | through surgery completion | 
| Surgery-related complications or death |  | 12 months | 
| Various causes of death |  | the perioperative period to 12 months | 
| Recurrence of target lesion |  | 12 months | 
| Target lesion was treated by interventional or surgical therapy once again |  | 12 months | 
| Postoperative ipsilateral symptomatic stroke | Ipsilateral symptomatic stroke is defined as the target lesion is conformed occurs ipsilateral stroke and the increase of NIHSS score point ≥4. | 30 days; 6 months; 12 months | 
| Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture |  | 12 months | 
| Occurs intracranial ischemic stroke that caused by thrombus |  | 12 months | 
| All adverse events |  | 12 months | 
| Device-related serious adverse events |  | 12 months | 
| Target lesion appears stenosis 12 months after surgery | Stenosis is defined as target stenosis ≥50% | 12 months | 
| Modified Rankin Scale |  | 30 days; 6 months; 12 months | 
| NIHSS |  | 30 days; 6 months; 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Willis, Intracranial aneurysms