Clinical trial NCT05692882: A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
Official title: To Evaluate the Safety and Efficacy of the NOVA Intracranial Drug-eluting Stent System in "real World" Patients with Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Post-marketing Registry Clinical Study (NOVA II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Arteriosclerosis
Stenosis Artery
Drug-Eluting Stents
Intracranial Artery Stenosis
Keywords: endovascular therapy
intracranial drug-eluting stent
symptomatic intracranial artery stenosis (sICAS)
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year after operation
Secondary outcomes:
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation
timeFrame: 30 days after operation
measure: Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after operation
timeFrame: 30 days after operation
measure: Rate of transient ischemic attack at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: 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
timeFrame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: 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
timeFrame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of symptomatic in-stent restenosis (ISR) and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: EuroQol-5D (EQ-5D) score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
timeFrame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
measure: Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional)
timeFrame: 1, 2, 3, 4 years and 5 years after operation
measure: Rate of Device defect
timeFrame: within 5 years of whole trial
measure: Rate of bleeding events at 1 years after operation
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Chenzhou
country: China
facility: First People's Hospital of Chenzhou
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
city: Shanxi
country: China
facility: Shanxi Cardiovascular Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zhongrong Zhongrong
role: PRINCIPAL_INVESTIGATOR
References: