Clinical Trial: New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry

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 Summary:

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.


Sponsor: Xuanwu Hospital, Beijing

Current Primary Outcome: 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%.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technically success rate of surgery [ Time Frame: immediately after surgery ]
    Technically success is defined as stent reach the target lesion and successfully released.
  • 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 [ Time Frame: 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.
  • 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 [ Time Frame: 12 months ]
    Stenosis is defined as target stenosis ≥50%
  • Modified Rankin Scale [ Time Frame: 30 days; 6 months; 12 months ]
  • NIHSS [ Time Frame: 30 days; 6 months; 12 months ]


Original Secondary Outcome: Same as current

Information By: Xuanwu Hospital, Beijing

Dates:
Date Received: June 23, 2016
Date Started: June 2016
Date Completion: May 2019
Last Updated: June 28, 2016
Last Verified: June 2016