Intracranial Atherosclerotic StenosisNCT06857058
Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis
A study testing NOVA DES in people with Intracranial Atherosclerotic Stenosis, run by Sino Medical Sciences Technology Inc. at 1 site in China.
Trial summary
The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Atherosclerotic Stenosis
- What is being tested?
- NOVA DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2024to 8 Jun 2026
- 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 80 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 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.);
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- The presence of a >50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of zhengzhou university
Zhengzhou
Sheng Guan
About this study
Official title: A Prospective, Multicenter, Registry Study to Evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis
The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.
Read the detailed description
The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. 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, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
- Conditions
- Intracranial Atherosclerotic Stenosis
- Being tested
- NOVA DES
- Keywords
- endovascular therapy, intracranial drug-eluting stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVA DESDevice
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 |
|---|---|---|
| NOVA DES | Experimental | Patients who met the inclusion criteria were implanted with the NOVA stent, and the procedure was documented in detail. Receives: Device: NOVA DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.
Measured: 1 year after procedure
Secondary outcomes (12)
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area
Measured: 30 days after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure
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 procedure
Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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 procedure
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 procedure
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 procedure
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 procedure
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 procedure
Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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 procedure
Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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 procedure
Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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 procedure
EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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.
Measured: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after procedure (Optional)
Patients with ≥50% stenosis of the vessel
Measured: 1, 2, 3, 4 years and 5 years after procedure
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 procedure
Bleeding was defined according to Bleeding Academic Research Consortium
Measured: 1 year after procedure
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 start8 Mar 2024
- Primary completion8 Jun 2026 (estimated)
- Study completion8 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Atherosclerotic StenosisStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheng Guan, Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityChun Fang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857058
- Sponsor's protocol ID
- SN-NOVA II SOP-202501
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- 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
- A Prospective, Multicenter, Registry Study to Evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT06857058
- Acronym / sponsor ID
- SN-NOVA II SOP-202501
- Conditions
- Intracranial Atherosclerotic Stenosis
- Keywords
- endovascular therapy, intracranial drug-eluting stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sino Medical Sciences Technology Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Tongji Hospital
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 8 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.
The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.
Detailed description
The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. 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, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOVA DES | Experimental | Device: NOVA DESPatients who met the inclusion criteria were implanted with the NOVA stent, and the procedure was documented in detail. |
Who may qualify
- Ages
- 18 to 80 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 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 |
|---|---|---|
| NOVA DESThe NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon | Device | NOVA DES |
Primary outcome
Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
Time frame: 1 year after procedure
This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.
12 secondary outcomes
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure
Time frame: 30 days after procedure
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure
Time frame: 30 days after procedure
Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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 procedure
Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
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 procedure
Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after procedure (Optional)
Time frame: 1, 2, 3, 4 years and 5 years after procedure
Rate of Device defect
Time frame: within 5 years of whole trial
Rate of bleeding events at 1 years after procedure
Time frame: 1 year after procedure
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.
Sheng Guan principal investigator
The First Affiliated Hospital of Zhengzhou University
Chun Fang principal investigator
Tongji Hospital
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 DES in people with Intracranial Atherosclerotic 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: 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 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?
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 Xiaoyan Yu (18614030565, yuxiaoyan@sinomed.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 after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure. (time frame: 1 year after procedure). 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.