Intracranial ArteriosclerosisNCT06857045
Comparison Three vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation
A study testing NOVA intracranial sirolimus-eluting stent system in people with Intracranial Arteriosclerosis and Intracranial Artery Stenosis, run by Sino Medical Sciences Technology Inc. at 1 site in China.
Trial summary
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aims to assess the clinical non-inferiority of 3 months (short-term) vs 6 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients after implanted NOVA intracranial sirolimus-eluting stent system. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Arteriosclerosis, Intracranial Artery Stenosis, Drug-Eluting Stents
- What is being tested?
- NOVA intracranial sirolimus-eluting stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 and 80 years of age.
- Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;.
- Intracranial artery stenosis (≥70%) conformed by DSA.
- Subjects who voluntarily participate in the study and sign informed consent form.
Who cannot join
- Subjects 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.
- Disabling stroke with a baseline mRS score ≥3.
- Lesion artery with severe calcification and close neighbour 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).
- The ischaemic event that is highly suspected to be due to vascular embolism from an extracranial arterial segment such as ipsilateral neck/chest arterial occlusion) or cardio embolism such as atrial fibrillation, mitral stenosis, left ventricular thrombus, patent foramen ovale, myocardial infarction within 6 weeks, etc.
Show all 12Show fewer
- More than 50% stenosis of the supplying artery of the lesion artery: 1) MCA severe stenosis (lesion artery) with more than 50% stenosis of ipsilateral ICA (supplying artery). 2) Basilar artery severe stenosis (lesion artery) with more than 50% stenosis of dominant VA (supplying artery) stenosis.
- Accompanied by intracranial tumours or intracranial arteriovenous malformations.
- The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components.
- Women who are pregnant or lactating.
- Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up.
- Investigators consider the patient who is not suitable for enrolling in the present trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Open-label, Randomized Controlled Trial of 3-month Versus 6-month Dual Antiplatelet Therapy After Implantation of NOVA Intracranial Sirolimus-eluting Stent System
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aims to assess the clinical non-inferiority of 3 months (short-term) vs 6 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients after implanted NOVA intracranial sirolimus-eluting stent system. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 months of DAPT at index procedure.
Read the detailed description
This study will recruit 478 subjects with intracranial atherosclerotic stenosis (ICAS) in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 6 months of DAPT after implanting NOVA stent. Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 1 year, 2 years, 3 years, 4 years and 5 years after index procedure. The primary endpoint is the composite endpoint of any stroke, death and major bleeding (intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery) at 1 year.
- Being tested
- NOVA intracranial sirolimus-eluting stent system
- Keywords
- 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.
NOVA intracranial sirolimus-eluting stent systemDevice
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 |
|---|---|---|
| 3 months DAPT Intervention | Experimental | After implantation of NOVA stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 3 months. Receives: Device: NOVA intracranial sirolimus-eluting stent system |
| 6 months DAPT Intervention | Active comparator | After implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 6 months. Receives: Device: NOVA intracranial sirolimus-eluting stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any stroke, death and major bleeding
Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery.
Measured: 1 year after operation
Secondary outcomes (13)
Any stroke or death within 30 days or any ischemic stroke 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 from the original culprit intracranial artery beyond 30 days through 12 months after operation.
Measured: 1 year after operation
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 TIA 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, 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 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, endovascularization 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
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 posted4 Mar 2025
- Study start9 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Subgroup analysis based on the main study (NCT05692882), not registered separately.
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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lianbo Gao, Principal investigator, The Fourth Affiliated Hospital of China Medical UniversityJianfeng Han, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857045
- Sponsor's protocol ID
- NOVA II-DAPT
- Status last verified
- Nov 2025
- First submitted
- 26 Feb 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Randomized Controlled Trial of 3-month Versus 6-month Dual Antiplatelet Therapy After Implantation of NOVA Intracranial Sirolimus-eluting Stent System
- ClinicalTrials.gov ID
- NCT06857045
- Acronym / sponsor ID
- NOVA II-DAPT
- Keywords
- intracranial drug-eluting stent, symptomatic intracranial artery stenosis (sICAS)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subgroup analysis based on the main study (NCT05692882), not registered separately.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sino Medical Sciences Technology Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Mar 2025 (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.
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aims to assess the clinical non-inferiority of 3 months (short-term) vs 6 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients after implanted NOVA intracranial sirolimus-eluting stent system. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 months of DAPT at index procedure.
Detailed description
This study will recruit 478 subjects with intracranial atherosclerotic stenosis (ICAS) in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 6 months of DAPT after implanting NOVA stent. Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 1 year, 2 years, 3 years, 4 years and 5 years after index procedure. The primary endpoint is the composite endpoint of any stroke, death and major bleeding (intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery) at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 months DAPT Intervention | Experimental | Device: NOVA intracranial sirolimus-eluting stent systemAfter implantation of NOVA stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 3 months. |
| 6 months DAPT Intervention | Active comparator | Device: NOVA intracranial sirolimus-eluting stent systemAfter implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 6 months. |
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 35 and 80 years of age.
- Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;.
- Intracranial artery stenosis (≥70%) conformed by DSA.
- Subjects who voluntarily participate in the study and sign informed consent form.
Key exclusion criteria (12 listed)
- Subjects 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.
- Disabling stroke with a baseline mRS score ≥3.
- Lesion artery with severe calcification and close neighbour 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 |
|---|---|---|
| NOVA intracranial sirolimus-eluting stent systemThe NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon. | Device | 3 months DAPT Intervention, 6 months DAPT Intervention |
Primary outcome
Any stroke, death and major bleeding
Time frame: 1 year after operation
Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery.
13 secondary outcomes
Any stroke or death within 30 days or any ischemic stroke from the original culprit intracranial artery beyond 30 days through 12 months after operation.
Time frame: 1 year after operation
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 TIA 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 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
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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Related trials for Intracranial Arteriosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingObservational study
China HEalthy Aging and Dementia Study (HEAD)
Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Not yet recruiting
EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease
Intracranial Atherosclerosis, Intracranial Arterial Stenosis
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
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. This study is not recruiting at the moment.
Lianbo Gao principal investigator
The Fourth Affiliated Hospital of China Medical University
Jianfeng Han principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVA intracranial sirolimus-eluting stent system in people with Intracranial Arteriosclerosis and Intracranial Artery Stenosis, run by Sino Medical Sciences Technology Inc. at 1 site 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: withdrawn, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any stroke, death and major bleeding (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 25 Nov 2025.