Intracranial ArteriosclerosisNCT05692882
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
A study testing Drug-Eluting Stents in people with Intracranial Arteriosclerosis and Stenosis Artery, run by Sino Medical Sciences Technology Inc. at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents
- What is being tested?
- Drug-Eluting Stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 5 sitesChina
- Study dates
- 16 Nov 2023to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.);
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Baixue Jia, MD contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
First People's Hospital of Chenzhou
Chenzhou
Xiaoxi Yao
- Recruiting
Ganzhou People's Hospital
Ganzhou
Guoyong Zeng
- Recruiting
Jinhua Municipal Central Hospital
Jinhua
Xiang Bao
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo
Shengjun Zhou
- Recruiting
Shanxi Cardiovascular Hospital
Shanxi
Tao Cheng
About this study
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)
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.
Read the 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.
- Conditions
- Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents, Intracranial Artery Stenosis
- Being tested
- Drug-Eluting Stents
- Keywords
- endovascular therapy, intracranial drug-eluting stent, symptomatic intracranial artery stenosis (sICAS)
- Medical subject headings
- Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Eluting StentsDevice
The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous transluminal angioplasty and stenting | Experimental | All patients will be implanted with Drug-Eluting Stents (NOVA DES). Receives: Device: Drug-Eluting Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.
Measured: 1 year after operation
Secondary outcomes (12)
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area
Measured: 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
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area
Measured: 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
Transient ischemic attack (TIA) is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours
Measured: 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
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area
Measured: 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
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the non-target blood supply area
Measured: 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
The cause of death was classified as vascular or nonvascular and based on information obtained from the family, medical records, and death certificates. Vascular death included death due to stroke, myocardial infarction (MI), heart failure, pulmonary embolus, cardiac arrhythmia, or other vascular cause.
Measured: 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
symptomatic ISR is defined as ISR associated with an ischemic event in the territory. Revascularization is the restoration or improvement of blood supply, and included surgical operation, endovascular procedures, etc.
Measured: 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
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Measured: 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
A health state defined by the descriptive EQ-5D system can be described by a five-digit number, each digit indicating the score of the corresponding dimension. For the description component a subject self-rates their health in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using either a three-level or a five-level scale.
Measured: 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)
Patients with ≥50% stenosis of the vessel
Measured: 1, 2, 3, 4 years and 5 years after operation
Rate of Device defect
Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.
Measured: within 5 years of whole trial
Rate of bleeding events at 1 years after operation
Bleeding was defined according to Bleeding Academic Research Consortium
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start16 Nov 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongrong Zhongrong, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692882
- Sponsor's protocol ID
- SN-NOVAII-202202
- Status last verified
- Mar 2024
- First submitted
- 9 Jan 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05692882
- Acronym / sponsor ID
- SN-NOVAII-202202
- Conditions
- Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents, Intracranial Artery Stenosis
- Keywords
- endovascular therapy, intracranial drug-eluting stent, symptomatic intracranial artery stenosis (sICAS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sino Medical Sciences Technology Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous transluminal angioplasty and stenting | Experimental | Device: Drug-Eluting StentsAll patients will be implanted with Drug-Eluting Stents (NOVA DES). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-Eluting StentsThe NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon | Device | Percutaneous transluminal angioplasty and stenting |
Primary outcome
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
The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baixue Jia, MD contact
Zhongrong Zhongrong principal investigator
Beijing Tiantan Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Eluting Stents in people with Intracranial Arteriosclerosis and Stenosis Artery, run by Sino Medical Sciences Technology Inc. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhongrong Miao, MD (+8613601243293, zhongrongm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.