Clinical Trial: Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms: a Multicenter, Uncontrolled, Exploratory Trial
Brief Summary: This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.
Detailed Summary:
Sponsor: National Cerebral and Cardiovascular Center
Current Primary Outcome:
- Safety evaluation: Any stroke or death related to the procedure within 180 days [ Time Frame: 180 days after the procedure ]
- Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure [ Time Frame: 180 days after the procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel) [ Time Frame: 180 days after the procedure ]
- Any death within 180 days after the procedure [ Time Frame: 180 days after the procedure ]
- Any death by neurological reason within 180 days after the procedure [ Time Frame: 180 days after the procedure ]
- Any adverse event or adverse device effect [ Time Frame: 180 days after the procedure ]
- Neurological assessment (scale ; mRS) [ Time Frame: 180 days after the procedure ]
- Neurological assessment (scale ; Barthel Index) [ Time Frame: 180 days after the procedure ]
- Neurological assessment (scale ; NIHSS) [ Time Frame: 30 days after the procedure ]
- Neurological assessment (scale ; GCS) [ Time Frame: 30 days after the procedure ]
Original Secondary Outcome: Same as current
Information By: National Cerebral and Cardiovascular Center
Dates:
Date Received: September 1, 2016
Date Started: May 2016
Date Completion: December 2018
Last Updated: September 15, 2016
Last Verified: September 2016