A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China

NCT05692882 | Recruiting DMC

• 1 other identifier: SN-NOVAII-202202
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Intracranial Arteriosclerosis; Stenosis Artery; Drug-Eluting Stents; Intracranial Artery Stenosis

Keywords

endovascular therapy; intracranial drug-eluting stent; symptomatic intracranial artery stenosis (sICAS)

Outcome Measures

Primary Outcomes (1)

• stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.

  The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.

  1 year after operation

Secondary Outcomes (12)

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

  30 days after operation

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

  30 days after operation

• Rate of transient ischemic attack at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

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

• 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 operation

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

• 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 operation

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

Study Arms (1)

Percutaneous transluminal angioplasty and stenting

EXPERIMENTAL

All patients will be implanted with Drug-Eluting Stents (NOVA DES).

Device: Drug-Eluting Stents

Interventions

Drug-Eluting Stents DEVICE

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

Percutaneous transluminal angioplasty and stenting

Eligibility Criteria

• Age: 18 Years - 85 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 digital subtraction angiography (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.);
• Target artery's supplying artery stenosis \> 50%. For example, patient with middle cerebral artery (MCA) severe stenosis (target artery) and the ipsilateral internal carotid artery (ICA) stenosis \> 50% should be excluded; patient with basilar artery (BA) severe stenosis (target artery) and the dominant vertical artery (VA) 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

Study Sites (5)

First People's Hospital of Chenzhou

Chenzhou, China

RECRUITING

Ganzhou People's Hospital

Ganzhou, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, China

RECRUITING

Shanxi Cardiovascular Hospital

Shanxi, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Zhongrong Zhongrong

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongrong Miao, MD

CONTACT

+8613601243293; zhongrongm@163.com

Baixue Jia, MD

CONTACT

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: January 9, 2023
• First Posted: January 20, 2023
• Study Start: November 16, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 1, 2025

Record last verified: 2024-03

Locations

CN (5)