New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm, Intracranial
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 100
- Locations
- 11
- Primary Endpoint
- 1-year treatment success rate
- Last Updated
- 9 years ago
Overview
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.
Investigators
Hongqi Zhang, MD
Cerebrovascular Expert Committee of Chinese Medical Doctor Association
Xuanwu Hospital, Beijing
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
Outcomes
Primary Outcomes
1-year treatment success rate
Time Frame: 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 Outcomes
- Target lesion treatment success rate(Immediately after surgery)
- X-ray exposure time(24 hours)
- Technically success rate of surgery(immediately after surgery)
- Target lesion was treated by interventional or surgical therapy once again(12 months)
- Postoperative ipsilateral symptomatic stroke(30 days; 6 months; 12 months)
- Operative time(through surgery completion)
- Surgery-related complications or death(12 months)
- All adverse events(12 months)
- Target lesion appears stenosis 12 months after surgery(12 months)
- Various causes of death(the perioperative period to 12 months)
- Recurrence of target lesion(12 months)
- Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture(12 months)
- Occurs intracranial ischemic stroke that caused by thrombus(12 months)
- Device-related serious adverse events(12 months)
- NIHSS(30 days; 6 months; 12 months)
- Modified Rankin Scale(30 days; 6 months; 12 months)