Status:
RECRUITING
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
Lead Sponsor:
Sino Medical Sciences Technology Inc.
Conditions:
Intracranial Arteriosclerosis
Stenosis Artery
Eligibility:
All Genders
18-85 years
Phase:
NA
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 steno...
Detailed Description
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 cent...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05692882
Start Date
November 16 2023
End Date
December 30 2029
Last Update
April 1 2025
Active Locations (5)
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1
First People's Hospital of Chenzhou
Chenzhou, China
2
Ganzhou People's Hospital
Ganzhou, China
3
Jinhua Municipal Central Hospital
Jinhua, China
4
The First Affiliated Hospital of Ningbo University
Ningbo, China