Clinical trial NCT02820779: New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
Official title: New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aneurysm, Intracranial
Carotid-Cavernous Sinus Fistula
Keywords: Willis
Intracranial aneurysms
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Harbin Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: Qilu Hospital of Shandong University
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Nanfang Hospital, Southern Medical University
name: Tang-Du Hospital
name: West China Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Shaanxi Provincial People's Hospital
name: Shandong Provincial Hospital
name: First Affiliated Hospital of Xinjiang Medical University
First posted: 2016-07-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-year treatment success rate
timeFrame: 12 months
Secondary outcomes:
measure: Technically success rate of surgery
timeFrame: immediately after surgery
measure: Target lesion treatment success rate
timeFrame: Immediately after surgery
measure: X-ray exposure time
timeFrame: 24 hours
measure: Operative time
timeFrame: through surgery completion
measure: Surgery-related complications or death
timeFrame: 12 months
measure: Various causes of death
timeFrame: the perioperative period to 12 months
measure: Recurrence of target lesion
timeFrame: 12 months
measure: Target lesion was treated by interventional or surgical therapy once again
timeFrame: 12 months
measure: Postoperative ipsilateral symptomatic stroke
timeFrame: 30 days; 6 months; 12 months
measure: Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture
timeFrame: 12 months
measure: Occurs intracranial ischemic stroke that caused by thrombus
timeFrame: 12 months
measure: All adverse events
timeFrame: 12 months
measure: Device-related serious adverse events
timeFrame: 12 months
measure: Target lesion appears stenosis 12 months after surgery
timeFrame: 12 months
measure: Modified Rankin Scale
timeFrame: 30 days; 6 months; 12 months
measure: NIHSS
timeFrame: 30 days; 6 months; 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital, Southern Medical university
state: Guangdong
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical university
state: Heilongjiang
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical university
state: Heilongjiang
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jinan
country: China
facility: Qilu Hospital Of Shang Dong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Taiyuan
country: China
facility: ShanXi Provincial People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: Tangdu Hospital Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Urumqi
country: China
facility: The First Affiliated Hospital Of Xinjiang Medical University
state: Xinjiang
city: Shanghai
country: China
facility: Tongji Hospital
Study officials:
affiliation: hqzh@vip.163.com
name: Hongqi Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: