Condition: Symptomatic Intracranial Atherosclerotic Stenosis · Sponsor: Beijing Tiantan Hospital
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subjects meeting all inclusion criteria and without any exclusion criteria will enter the investigation after providing written informed consent via ethics committee-approved informed consent forms (ICFs). The randomized controlled study plans to enroll 224 patients, stratified by intracranial lesion location (anterior/posterior circulation), through a centralized randomization system. The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting Stent System (RICOTON Technology Co., Ltd.), while the control group will receive the NOVADES® Intracranial Drug-Eluting Stent System. All subjects underwent follow-up visits on the day of the procedure, within 7 days postoperatively or prior to discharge, and at 30 days, 6 months, and 12 months postoperatively.
This description comes directly from the study's public registry record.
Feng Gao, Ph.D · 13581936066 · geofengletter@sina.com
Ming Yang · 13331060083 · wireyang20@163.com
Always discuss trial participation with your own doctor first.
| A prospective, multi-center, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the NxiDIME™ Intracranial Drug-Eluting Stent System in the treatment of symptomatic intracranial atherosclerotic stenosis lesions | Beijing, Beijing Municipality, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07197970