ClinicalTrials.gg
RecruitingNCT05692882Updated Apr 1, 2025

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

An interventional study of Drug-Eluting Stents in Intracranial Arteriosclerosis, Stenosis Artery and Drug-Eluting Stents, sponsored by Sino Medical Sciences Technology Inc.. Recruiting at 5 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Sino Medical Sciences Technology Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 44 studies in Intracranial Arteriosclerosis with a site in China — 28 open to participants now, 28 under way, 2 of them phase 3. Intracranial Arteriosclerosis · China.

Planned enrollment
5th of 27
1,000 · median 200
Started
2023
with 8 others
No phase
16 of 44
8 open now
Primary completion
2025-12
later than 8 of 27 live
Registered
25th of 44
by date
Lead sponsor
2 of 44
Sino Medical Sciences Technology Inc.

Among the 44 studies in Intracranial Arteriosclerosis with a site in China, this one is the 5th largest by planned enrollment of the 27 interventional ones that give a count, is one of 9 that started in 2023, is one of 16 with no phase, reaches primary completion later than 8 of the 27 other live ones, and was the 25th registered.

Intracranial Arteriosclerosis

102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.

Browse Intracranial Arteriosclerosis studies →

Open to participants now

28 of the 44 studies in Intracranial Arteriosclerosis with a site in China are open now. Recruiting first, the newest first:

22 more — sign in →

All 28 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 28 Intracranial Arteriosclerosis studies recruiting now, 11 (39%) set no upper age limit and 1 (4%) stops at 75 or younger; none take children under 18; 2 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 44 studies in Intracranial Arteriosclerosis with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Intracranial Arteriosclerosis
  • Stenosis Artery
  • Drug-Eluting Stents
  • Intracranial Artery Stenosis

Keywords

  • endovascular therapy
  • intracranial drug-eluting stent
  • symptomatic intracranial artery stenosis (sICAS)
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males or females between 18 and 80 years of age;
  2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;
  3. intracranial artery stenosis ( ≥70%) conformed by digital subtraction angiography (DSA);
  4. Those who voluntarily participate in the study and sign form.

Exclusion criteria

Exclusion Criteria:

  1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
  2. Subjects of acute hemorrhagic stroke within 3 months;
  3. The baseline mRS of disabling stroke is more than 3;
  4. The target vessel is severely calcified and closely related to stenosis;
  5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
  6. 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.);
  7. 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;
  8. There are intracranial tumors, or intracranial arteriovenous malformations;
  9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
  10. Pregnant and lactating women
  11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
  12. Inapplicable for this study at the investigators' viewpoints.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Percutaneous transluminal angioplasty and stenting

    All patients will be implanted with Drug-Eluting Stents (NOVA DES).

    Device: Drug-Eluting Stents

Interventions

  • DeviceDrug-Eluting Stents

    The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year after operation

Secondary outcomes

  1. 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

    Time frame: 30 days after operation

  2. 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

    Time frame: 30 days after operation

  3. 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

    Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  4. 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

    Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  5. 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

    Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  6. 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.

    Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  7. 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.

    Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  8. 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.

    Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  9. 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.

    Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation

  10. Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional)

    Patients with ≥50% stenosis of the vessel

    Time frame: 1, 2, 3, 4 years and 5 years after operation

  11. 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.

    Time frame: within 5 years of whole trial

  12. Rate of bleeding events at 1 years after operation

    Bleeding was defined according to Bleeding Academic Research Consortium

    Time frame: 1 year after operation

07

Study locations

5 of 5 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2023
First posted
Jan 20, 2023
StartActual
Nov 16, 2023
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2029
Last update
Apr 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05692882
Lead sponsor
Sino Medical Sciences Technology Inc.
Responsible party
Sponsor
First posted
Jan 20, 2023
Start date
Nov 16, 2023
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2029 (estimated)
Last update
Apr 1, 2025

Study contacts

Zhongrong Miao, MD
Contact
zhongrongm@163.com
+8613601243293
Baixue Jia, MD
Contact
Zhongrong Zhongrong
principal investigator · Beijing Tiantan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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