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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
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
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%.
Time frame: 12 months
Technically success rate of surgery
Technically success is defined as stent reach the target lesion and successfully released.
Time frame: immediately after surgery
Target lesion treatment success rate
Time frame: Immediately after surgery
X-ray exposure time
Time frame: 24 hours
Operative time
Time frame: through surgery completion
Surgery-related complications or death
Time frame: 12 months
Various causes of death
Time frame: the perioperative period to 12 months
Recurrence of target lesion
Time frame: 12 months
Target lesion was treated by interventional or surgical therapy once again
Time frame: 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.
Time frame: 30 days; 6 months; 12 months
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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
...and 1 more locations
Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture
Time frame: 12 months
Occurs intracranial ischemic stroke that caused by thrombus
Time frame: 12 months
All adverse events
Time frame: 12 months
Device-related serious adverse events
Time frame: 12 months
Target lesion appears stenosis 12 months after surgery
Stenosis is defined as target stenosis ≥50%
Time frame: 12 months
Modified Rankin Scale
Time frame: 30 days; 6 months; 12 months
NIHSS
Time frame: 30 days; 6 months; 12 months