ClinicalTrials.gg
RecruitingNCT06857058Updated Apr 1, 2025

Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

An interventional study of NOVA DES in Intracranial Atherosclerotic Stenosis, sponsored by Sino Medical Sciences Technology Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 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 Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Mar 2024, registered Feb 2025).
  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

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

Among 81 studies in Constriction, Pathologic with a site in China — 37 open to participants now, 40 under way, 3 of them phase 3. Constriction, Pathologic · China.

Planned enrollment
10th of 56
300 · median 145
Started
2024
with 11 others
No phase
48 of 81
21 open now
Primary completion
2026-06
later than 13 of 39 live
Registered
64th of 81
by date

Among the 81 studies in Constriction, Pathologic with a site in China, this one is the 10th largest by planned enrollment of the 56 interventional ones that give a count, is one of 12 that started in 2024, is one of 48 with no phase, reaches primary completion later than 13 of the 39 other live ones, and was the 64th registered.

Constriction, Pathologic

457 studies on the registry are indexed under Constriction, Pathologic; 110 are open to participants now.

Browse Constriction, Pathologic studies →

Open to participants now

37 of the 81 studies in Constriction, Pathologic with a site in China are open now. Recruiting first, the newest first:

31 more — sign in →

All 37 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 67 Constriction, Pathologic studies recruiting now, 34 (51%) set no upper age limit and 14 (21%) stop at 75 or younger; 8 take children under 18; 1 takes healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 81 studies in Constriction, Pathologic 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 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.

03

Conditions studied

  • Intracranial Atherosclerotic Stenosis

Keywords

  • endovascular therapy, intracranial drug-eluting stent
04

Who can participate

Ages eligible
18 Years to 80 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 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. 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;
  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
300 participants (estimated)

Study arms

  • Experimental
    NOVA DES

    Patients who met the inclusion criteria were implanted with the NOVA stent, and the procedure was documented in detail.

    Device: NOVA DES

Interventions

  • DeviceNOVA DES

    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 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.

    Time frame: 1 year after procedure

Secondary outcomes

  1. 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

    Time frame: 30 days after procedure

  2. 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

    Time frame: 30 days after procedure

  3. 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

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

  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 procedure

    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 procedure

  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 procedure

    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 procedure

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

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

    Patients with ≥50% stenosis of the vessel

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

  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 procedure

    Bleeding was defined according to Bleeding Academic Research Consortium

    Time frame: 1 year after procedure

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Jun 2026, 27 months after the start.

Of 43 industry-sponsored interventional studies with no phase under Constriction, Pathologic, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 58. This study's planned 27 months is below that.

Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 53.

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

Registered
Feb 26, 2025
First posted
Mar 4, 2025
StartActual
Mar 8, 2024
Primary completionEst.
Jun 8, 2026
CompletionEst.
Jun 8, 2026
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
NCT06857058
Lead sponsor
Sino Medical Sciences Technology Inc.
Responsible party
Sponsor
First posted
Mar 4, 2025
Start date
Mar 8, 2024
Primary completion
Jun 8, 2026 (estimated)
Completion
Jun 8, 2026 (estimated)
Last update
Apr 1, 2025

Study contacts

Xiaoyan Yu
Contact
yuxiaoyan@sinomed.com
18614030565
Sheng Guan
principal investigator · The First Affiliated Hospital of Zhengzhou University
Chun Fang
principal investigator · Tongji 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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