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

Last updated: March 26, 2025
Sponsor: Sino Medical Sciences Technology Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

NOVA DES

Clinical Study ID

NCT06857058
SN-NOVA II SOP-202501
  • Ages 18-80
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  1. Those who have surgery within previous 30 days or plan to perform major surgery inthe 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, vascularinflammatory lesions caused by infection, autoimmune diseases, post-irradiation,postpartum status; developmental or genetic abnormalities such as fibromusculardysplasia, sickle cell anemia, suspected vasospasm);

  6. It is suspected that the ischemic event is due to embolism or arterial embolism fromthe extracranial segment (including ipsilateral chest or neck vascular occlusivedisease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitralstenosis, patent foramen ovale, left ventricular thrombus, myocardial infarctionwithin 6 weeks, etc.);

  7. The presence of a >50% stenosis in the main blood supply artery of the targetvessel. For example, when the lesion is located in the middle cerebral artery, theipsilateral internal carotid artery stenosis by over 50% should be excluded; whenthe lesion is located in the basilar artery, the dominant side vertebral arterystenosis >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 oremotional disorders;

  12. Inapplicable for this study at the investigators' viewpoints.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: NOVA DES
Phase:
Study Start date:
March 08, 2024
Estimated Completion Date:
June 08, 2026

Study Description

The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are 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.

Connect with a study center

  • The first affiliated hospital of zhengzhou university

    Zhengzhou,
    China

    Active - Recruiting

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