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

NCT ID: NCT06857058

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2026-06-08

Brief 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.

Detailed 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.

Conditions

Intracranial Atherosclerotic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NOVA DES

Patients who met the inclusion criteria were implanted with the NOVA stent, and the procedure was documented in detail.

Group Type: EXPERIMENTAL

NOVA DES

Intervention Type: DEVICE

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

Interventions

NOVA DES

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Sino Medical Sciences Technology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheng Guan

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Chun Fang

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

The first affiliated hospital of zhengzhou university

Zhengzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Yu

Role: CONTACT

yuxiaoyan@sinomed.com

18614030565

Facility Contacts

Sheng Guan

Role: primary

Other Identifiers

SN-NOVA II SOP-202501

Identifier Type: -

Identifier Source: org_study_id