NCT07197970

Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Symptomatic Intracranial Atherosclerotic Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-15
• Primary completion: 2027-05-15
• Completion: 2027-05-15
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China