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| Name | Class |
|---|---|
| First Affiliated Hospital of Harbin Medical University | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WILLIS | Experimental | Patients undergo WILLIS intracranial covered stent interventional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WILLIS | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongqi Zhang, MD | Contact | hqzh@vip.163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongqi Zhang, MD | hqzh@vip.163.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang hospital, Southern Medical university | Guangzhou | Guangdong | 510515 | China | ||
| The 2nd Affiliated Hospital of Harbin Medical university |
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| Shanghai Tongji Hospital, Tongji University School of Medicine |
| OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Tang-Du Hospital | OTHER |
| West China Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
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|
| 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 |
| Harbin |
| Heilongjiang |
| 150001 |
| China |
| The First Affiliated Hospital of Harbin Medical university | Harbin | Heilongjiang | 150001 | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Qilu Hospital Of Shang Dong University | Jinan | Shandong | 250012 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| ShanXi Provincial People's Hospital | Taiyuan | Shanxi | 030012 | China |
| Tangdu Hospital Fourth Military Medical University | Xi’an | Shanxi | 710038 | China |
| West China Hospital Sichuan University | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital Of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| Tongji Hospital | Shanghai | 200333 | China |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D020216 | Carotid-Cavernous Sinus Fistula |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000096826 | Cavernous Sinus Syndromes |
| D002340 | Carotid Artery Diseases |
| D020212 | Carotid Artery Injuries |
| D020214 | Cerebrovascular Trauma |
| D020196 | Trauma, Nervous System |
| D001164 | Arteriovenous Fistula |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D016157 | Vascular Fistula |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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