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Intracranial Arterial DiseasesNCT05217459

The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

A study testing Self-expanding intracranial drug stent system in people with Intracranial Arterial Diseases and Stent Restenosis, run by Sinomed Neurovita Technology Inc. at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis. Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
Self-expanding intracranial drug stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
14 sitesChina
Study dates
4 Jul 2022to 29 Mar 2024
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 30 to 75 years of age;
  • Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
  • Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery
  • The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
  • The target lesion reference diameter must be visually estimated to be ≥2.0 mm and <4.5mm in diameter, and lesion length of ≤34 mm;
  • mRS < 3;
  • The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
  • Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.

Who cannot join

  • The target vessels was complete occlusion;
  • >70% stenosis observed at the intracranial large-vessel distal to the target vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
  • Preoperative magnetic resonance only showed perforating infarction in the target lesion area;
  • Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
  • Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
  • CT showed Severe calcified lesions;
Show all 19Show fewer
  • Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
  • Non-atherosclerosis lesions;
  • Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
  • Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
  • Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents;
  • Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;
  • Uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)；
  • Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, Serum creatinine>250μmol/L);
  • Life expectancy < 1 year;
  • Pregnant/lactating female patients;
  • Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis);
  • Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint;
  • Inapplicable for intravascular stenting treatment as per investigators judgment.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • The First People's Hospital of Changzhou

    Changzhou

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The First Affiliated Hospital of Harbin Medical University

    Ha’erbin

  • Hangzhou First people's Hospital, Zhejiang University School of Medicine

    Hangzhou

  • The First Affiliated Hospital of USTC Anhui provincial hospital

    Hefei

  • Qilu Hospital, Shandong University

    Jinan

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Changhai Hospital

    Shanghai

  • Shanghai Fourth People's Hospital

    Shanghai

  • The First Hospital of Hebei Medical University

    Shijiazhuang

  • Yantai Yu Huang Ding hospital

    Yantai

  • The First Affiliated hospital of Zhengzhou hospital

    Zhengzhou

Other trials in China

About this study

Official title: A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

Read the detailed description

This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Being tested
Self-expanding intracranial drug stent system
Keywords
Self-expanding intracranial stent, Symptomatic Intracranial Atherosclerotic Disease, In-stent restenosis
Medical subject headings
Intracranial Arterial Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-expanding intracranial drug stent systemDevice

    All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)

Study groups in NCT05217459
Study groupRoleWhat they receive
Self-expanding intracranial drug stent systemExperimentalAll patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)
Receives: Device: Self-expanding intracranial drug stent system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of In-stent restenosis within 6 months after operation

    ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.

    Measured: 6 months after operation

Secondary outcomes (15)

  1. Stent success

    Stent success is defined as ISS is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.

    Measured: Immediately after operative

  2. Procedure success

    Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.

    Measured: Immediately after operative

  3. Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up

    The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).

    Measured: 6 months after operation

  4. Rate of good functional outcomes measured by Modified Rankin Score (mRS)

    Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2.

    Measured: 30days, 6 months, 1 year after operation

  5. Rate of all revascularization and target lesion revascularization

    The proportion of patients who had revascularization in target lesion or not

    Measured: 30days, 31days to 6 months, 1 year after operation

  6. Symptomatic ISR within 6 months

    Symptomatic ISR is defined as ISR associated with ischemic event in the territory

    Measured: within 6 months

  7. Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.

    As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.

    Measured: 30days, 31days to 6 months, 1 year after operation

  8. Any stroke or death within 30 days after operation

    Any stroke, death means death from any cause, including stroke or cerebrovascular disease

    Measured: Within 30 days after operation

  9. Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel

    The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion

    Measured: Within 30 days after operation

  10. The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.

    There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.

    Measured: 31days to 6 months, 1 year after operation

  11. The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation.

    There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.

    Measured: 31 days to 6 months, 1 year after operation

  12. Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage

    There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage

    Measured: 31 days to 6 months, 1 year after operation

  13. All cause death

    The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year after operation

    Measured: 31days to 6 months, 1 year after operation

  14. Adverse events or severe adverse event

    The proportion of Adverse events or severe adverse event

    Measured: 31 days to 6 months, 1 year after operation

  15. Incidence of device defects

    The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.

    Measured: During operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start4 Jul 2022
  3. Primary completion17 Aug 2023
  4. Study completion29 Mar 2024

Resources

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
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05217459
Sponsor's protocol ID
SNSC-202103
Status last verified
May 2024
First submitted
4 Jan 2022
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-expanding intracranial drug stent system in people with Intracranial Arterial Diseases and Stent Restenosis, run by Sinomed Neurovita Technology Inc. at 14 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The incidence of In-stent restenosis within 6 months after operation (time frame: 6 months after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05217459.

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 21 May 2025.

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