Sinomed Neurovita Technology Inc.
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.
Intracranial Arteriosclerosis
Stenosis Artery
Drug-Eluting Stents
Intracranial Artery Stenosis
Drug-Eluting Stents
Not Applicable
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 |
Estimated Enrollment : | 1000 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | April 1, 2023 |
Estimated Primary Completion Date : | December 30, 2025 |
Estimated Study Completion Date : | December 30, 2029 |
Arm | Intervention/treatment |
---|---|
Experimental: Percutaneous transluminal angioplasty and stenting All patients will be implanted with Drug-Eluting Stents (NOVA DES). |
Device: Drug-Eluting Stents |
Ages Eligible for Study: | 18 Years to 85 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.