Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT07197970

Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

Led by Beijing Tiantan Hospital · Updated on 2025-09-30

224

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Drug- Eluting Stent for Symptomatic Intracranial Arterial Stenosis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years, any gender
  • Symptomatic intracranial arterial stenosis causing TIA or ischemic stroke within 180 days, with 70% to 99% narrowing measured by DSA
  • Currently receiving at least one antiplatelet therapy
  • Poor collateral blood flow or reduced blood flow in the target artery territory as shown by imaging
  • Target artery diameter between 1.0 and 5.5 mm with lesion length up to 40 mm
  • Modified Rankin Scale (mRS) score of 2 or below
  • Voluntary participation with signed informed consent and willingness to follow study procedures and visits
Not Eligible

You will not qualify if you...

  • Prior stent placement or surgery at the target lesion
  • Intracranial bleeding within 30 days before the procedure or untreated chronic subdural hematoma larger than 5 mm
  • Major surgery within 30 days before the procedure
  • Acute ischemic stroke within 14 days before the procedure
  • Significant carotid stenosis outside target lesion needing treatment
  • Severe vessel calcification, narrowing, or twisting that prevents stent placement
  • Presence of intracranial tumors, arteriovenous malformations, or aneurysms near the target lesion
  • Non-atherosclerotic causes of stenosis like arterial dissection or vasculitis
  • Cardiac sources of embolism such as atrial fibrillation or recent heart attack
  • Uncontrolled high blood pressure (SBP ≥180 mmHg or DBP ≥110 mmHg)
  • Contraindications to blood thinners or clotting disorders
  • Severe heart, lung, or kidney failure or active cancer
  • Allergies to stent materials or contrast agents
  • Life expectancy less than 1 year
  • Pregnancy, breastfeeding, or planned pregnancy within 1 year
  • Participation in other clinical trials without completing primary endpoint follow-up
  • Cognitive or psychiatric conditions impairing study compliance
  • Other conditions judged by investigators to exclude participation

AI-Screening

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Trial Site Locations

Total: 1 location

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, 100000

Actively Recruiting

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Research Team

F

Feng Gao, Ph.D

CONTACT

M

Ming Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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