Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06857058

Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

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

300

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

Sponsors

S

Sino Medical Sciences Technology Inc.

Lead Sponsor

T

The First Affiliated Hospital of Zhengzhou University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.

CONDITIONS

Official Title

Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

Who Can Participate

Age: 18Years - 80Years
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 DSA
  • Voluntarily willing to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Surgery within the previous 30 days or planned major surgery in the next 90 days (grade 3 or above)
  • Acute hemorrhagic stroke within 3 months
  • Baseline 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
  • Ischemic event suspected to be due to embolism or cardiogenic embolism
  • More than 50% stenosis in the main blood supply artery of the target vessel
  • Presence of intracranial tumors or arteriovenous malformations
  • Allergy 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 judgment that the subject is not suitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The first affiliated hospital of zhengzhou university

Zhengzhou, China

Actively Recruiting

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Research Team

X

Xiaoyan Yu

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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Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis | DecenTrialz