About this trial

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.

Eligibility criteria

Qualifiers

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%) conformed by digital subtraction angiography (DSA);

Those who voluntarily participate in the study and sign informed consent form.

Disqualifiers

Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);

Subjects of acute hemorrhagic stroke within 3 months;

The baseline mRS of disabling stroke is more than 3;

The target vessel is severely calcified and closely related to stenosis;

Trial design

Treatments tested in this trial

  • Drug-Eluting Stents

Treatment groups

1,000 Participants
are divided into 1 treatment group

Locations

5
First People's Hospital of Chenzhou Chenzhou China
Ganzhou People's Hospital Ganzhou China
Jinhua Municipal Central Hospital Jinhua China
The First Affiliated Hospital of Ningbo University Ningbo China

Sponsors and collaborators

Sino Medical Sciences Technology Inc.

Lead sponsor