Aneurysm, Intracranial, Carotid-Cavernous Sinus Fistula
Conditions
Keywords
Willis, Intracranial aneurysms
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.
Interventions
DEVICEWILLIS
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.
Sponsors
First Affiliated Hospital of Harbin Medical University
The Second Affiliated Hospital of Harbin Medical University
Qilu Hospital of Shandong University
Shanghai Tongji Hospital, Tongji University School of Medicine
Nanfang Hospital, Southern Medical University
Tang-Du Hospital
West China Hospital
The First Affiliated Hospital of Zhengzhou University
Shaanxi Provincial People's Hospital
Shandong Provincial Hospital
First Affiliated Hospital of Xinjiang Medical University
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Technically success rate of surgery | immediately after surgery | Technically success is defined as stent reach the target lesion and successfully released. |
| 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 | 12 months | Stenosis is defined as target stenosis ≥50% |
| Modified Rankin Scale | 30 days; 6 months; 12 months | — |
| NIHSS | 30 days; 6 months; 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. |
Countries
China
Contacts
Primary ContactHongqi Zhang, MD
Outcome results
None listed