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Recruiting NCT05692882

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

No phase Interventional Intracranial Arteriosclerosis Stenosis Artery Drug-Eluting Stents Intracranial Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug-Eluting Stents.
Who it may be relevant to
Registry conditions: Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents, Intracranial Artery Stenosis. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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.

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.

Interventions

  • Device Drug-Eluting Stents
    The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

Primary outcome measures

  • 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. [Time frame: 1 year after operation]
Secondary outcome measures (12)
  • Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation [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 [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 [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 [Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation]
  • 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 [Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation]
  • Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation [Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation]
  • 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 [Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation]
  • Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation [Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation]
  • EuroQol-5D (EQ-5D) score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation [Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation]
  • Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional) [Time frame: 1, 2, 3, 4 years and 5 years after operation]
  • Rate of Device defect [Time frame: within 5 years of whole trial]
  • Rate of bleeding events at 1 years after operation [Time frame: 1 year after operation]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • First People's Hospital of Chenzhou — Chenzhou
  • Ganzhou People's Hospital — Ganzhou
  • Jinhua Municipal Central Hospital — Jinhua
  • The First Affiliated Hospital of Ningbo University — Ningbo
  • Shanxi Cardiovascular Hospital — Shanxi

Identifiers

NCT: NCT05692882 · SN-NOVAII-202202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗