First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Location status: Recruiting
NCT Number: NCT06189950
This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Zhengzhou, Henan, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intracranial stent for wide-necked aneurysms
Time frame: 6 months
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm.
Adequate occlusion rate includes Class I and Class II
Time frame: immediately after the procedure
Technical successwas defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.
Time frame: 6 months
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm.
Complete occlusion rate includes Class I
Time frame: 6 months
Time frame: 1 year
Time frame: 1 year
Time frame: 1 year
Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up
Contact information is provided by the study sponsor or research team.
MicroPort NeuroTech Co., Ltd.
Industry
a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Intracranial Stent for the Treatment of Intracranial Aneurysms: Rebridge
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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