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

NCT06857058 | Recruiting DMC

• 1 other identifier: SN-NOVA II SOP-202501
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Atherosclerotic Stenosis

Keywords

endovascular therapy, intracranial drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 year after procedure

Secondary Outcomes (12)

• Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure

  30 days after procedure

• Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure

  30 days after procedure

• Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

  30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

• Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

  3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

• Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

  3, 6 months, 1, 2, 3, 4 years and 5 years after procedure

Study Arms (1)

NOVA DES

EXPERIMENTAL

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

Device: NOVA DES

Interventions

NOVA DES DEVICE

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

NOVA DES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• 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);
• 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.);
• 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;
• There are intracranial tumors, or intracranial arteriovenous malformations;
• Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
• Pregnant and lactating women
• Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
• Inapplicable for this study at the investigators' viewpoints.

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

The first affiliated hospital of zhengzhou university

Zhengzhou, China

RECRUITING

Study Officials

• Sheng Guan

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Chun Fang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Yu

CONTACT

18614030565; yuxiaoyan@sinomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 8, 2024
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): June 8, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-02

Locations

CN (1)