Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05692882

A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China

Led by Sino Medical Sciences Technology Inc. · Updated on 2025-04-01

1000

Participants Needed

5

Research Sites

319 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The primary objective of this trial is to evaluate the long-term safety and efficacy of the NOVA intracranial drug-eluting stent system in "real world" patients with intracranial atherosclerotic stenosis.

CONDITIONS

Official Title

A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females between 18 and 80 years of age
  • Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
  • Intracranial artery stenosis (≥70%) confirmed by digital subtraction angiography (DSA)
  • Voluntary participation with signed informed consent form
Not Eligible

You will not qualify if you...

  • Surgery within previous 30 days or planned major surgery in next 90 days
  • Acute hemorrhagic stroke within 3 months
  • Baseline modified Rankin Scale (mRS) score for disabling stroke greater than 3
  • Target vessel severely calcified and closely related to stenosis
  • Non-atherosclerotic diseases such as arterial dissection, Moya Moya disease, vascular inflammatory lesions, autoimmune diseases, post-irradiation, postpartum status, developmental or genetic abnormalities
  • Suspected ischemic event due to embolism from extracranial segment or cardiogenic embolism
  • Target artery's supplying artery stenosis greater than 50%
  • Presence of intracranial tumors or arteriovenous malformations
  • Allergies to heparin, aspirin, clopidogrel, contrast agents, anesthetics, or stent components
  • Pregnant or lactating women
  • Unable to complete follow-up due to mental illness, cognitive or emotional disorders
  • Investigator's judgement that participation is not suitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

First People's Hospital of Chenzhou

Chenzhou, China

Actively Recruiting

2

Ganzhou People's Hospital

Ganzhou, China

Actively Recruiting

3

Jinhua Municipal Central Hospital

Jinhua, China

Actively Recruiting

4

The First Affiliated Hospital of Ningbo University

Ningbo, China

Actively Recruiting

5

Shanxi Cardiovascular Hospital

Shanxi, China

Actively Recruiting

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Research Team

Z

Zhongrong Miao, MD

CONTACT

B

Baixue Jia, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China | DecenTrialz