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

Sino Medical Sciences Technology Inc.1,000 enrolled

Overview

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.

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from December 2022 to December 2030 with 1000 subjects recruited in around 50 Chinese centers. 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, operation date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary outcome was a composite of 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Intracranial Arteriosclerosis Stenosis Artery Drug-Eluting Stents Intracranial Artery Stenosis

Interventions

Drug-Eluting StentsDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 digital subtraction angiography (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. 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; 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.

Locations (5)

First People's Hospital of Chenzhou

Chenzhou, China

RECRUITING

Ganzhou People's Hospital

Ganzhou, China

RECRUITING

Jinhua Municipal Central Hospital

Jinhua, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year after operation

Secondary Outcomes

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

The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area

Time frame: 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

The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area

Time frame: 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

Transient ischemic attack (TIA) is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours

Time frame: 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

The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area

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

Central Contacts

Zhongrong Miao, MD

CONTACT

+8613601243293 zhongrongm@163.com

Baixue Jia, MD

CONTACT

Data from ClinicalTrials.gov

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