Actively Recruiting
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)
Led by Sino Medical Sciences Technology Inc. · Updated on 2025-04-01
1000
Participants Needed
5
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the device's performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.
CONDITIONS
Brief Title
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females between 18 and 80 years of age
- Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
- Intracranial artery stenosis of 70% or greater confirmed by digital subtraction angiography (DSA)
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Major surgery within the previous 30 days or planned major surgery within the next 90 days
- Acute hemorrhagic stroke within the last 3 months
- Baseline modified Rankin Scale score greater than 3 indicating disabling stroke
- Target vessel severely calcified near stenosis
- Non-atherosclerotic diseases such as arterial dissection, Moya Moya disease, vascular inflammation from infection or autoimmune causes, post-irradiation, postpartum status, or genetic abnormalities
- Suspected ischemic event due to embolism from extracranial arteries or cardiogenic sources
- Target artery's supplying artery stenosis greater than 50%
- Presence of intracranial tumors or arteriovenous malformations
- Allergies to heparin, aspirin, clopidogrel, contrast agents, anesthetics, or stent components
- Pregnant or lactating women
- Inability to complete follow-up due to mental illness or cognitive/emotional disorders
- Considered unsuitable for the study by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the Drug-Eluting Stent (NOVA DES) for treatment of intracranial atherosclerotic stenosis.
1 visit (in-person) on operation date
Duration - 5 years
Participants are monitored through multiple follow-up visits to assess safety and efficacy of the stent, including stroke or death rates and other clinical outcomes.
9 visits at 30 days, 3 months, 6 months, 1, 2, 3, 4, and 5 years after operation
Trial Site Locations
Total: 5 locations
1
First People's Hospital of Chenzhou
Chenzhou, China
Actively Recruiting
2
Ganzhou People's Hospital
Ganzhou, China
Actively Recruiting
3
Jinhua Municipal Central Hospital
Jinhua, China
Actively Recruiting
4
The First Affiliated Hospital of Ningbo University
Ningbo, China
Actively Recruiting
5
Shanxi Cardiovascular Hospital
Shanxi, China
Actively Recruiting
Research Team
Z
Zhongrong Miao, MD
B
Baixue Jia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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