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New treatment option for Intracranial Arteriosclerosis
Official title A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
ClinicalTrials.gov ID: NCT05692882
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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.
You likely can't join if
- Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
- people 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...
- It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck...
See the full eligibility 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.
- Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
- people 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chenzhou, China
- Ganzhou, China
- Jinhua, China
- Ningbo, China
- Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chenzhou, China; Ganzhou, China; Jinhua, China; Ningbo, China; Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.