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RECRUITING
NCT07197970
PHASE3

Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Multi-center, Randomized Controlled, Clinical Trial to Evaluate the Safety and Efficacy of NxiDIME™ Intracranial Drug-eluting Self-expanding Stent System

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2025-05-15

Completion Date

2027-05-15

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

DEVICE

NxiDIME™ Intracranial Drug-Eluting Stent System

The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting self-expanding Stent System (RICOTON Technology Co., Ltd.)

DEVICE

NOVA DES Intracranial Drug-Eluting Stent

The experimental group will receive the NOVA DES Intracranial Drug-Eluting balloon-expandable stent System

Locations (1)

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