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Recruiting Not applicable

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

NCT06857058 · tracked via the Priya Life Science China tracker
Sponsor
Sino Medical Sciences Technology Inc
Phase
Not applicable
Started
2024-03-08
Last updated
2025-04-01

Condition(s) studied

Intracranial Atherosclerotic Stenosis

Investigational drug(s) / intervention(s)

NOVA DES

NOVA DES: The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Males or females between 18 and 80 years of age 2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm 3. Intracranial artery stenosis ( ≥70%) conformed by DSA 4. Those who voluntarily participate in the study and sign informed consent form Exclusion Criteria: 1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above); 2. Subjects of acute hemorrhagic stroke within 3 months; 3. The baseline mRS of disabling stroke is more than 3; 4. The target vessel is severely calcified and closely related to stenosis; 5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm); 6. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.); 7. The presence of a \>50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis \>50% should be excluded; 8. There are intracranial tumors, or intracranial arteriovenous malformations; 9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components; 10. Pregnant and lactating women 11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders; 12. Inapplicable for this study at the investigators' viewpoints.

Primary outcome measure(s)

  • Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure. — 1 year after procedure
    This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of zhengzhou university Zhengzhou China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06857058 on ClinicalTrials.gov ↗ ← All trials in China