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Cerebral IschemiaNCT04821726

DEB for Symptomatic Intracranial Atherosclerosis Stenosis

A study testing Drug eluting balloon (Vmoky) in people with Cerebral Ischemia and Cerebral Atherosclerosis, run by Yinyi(Liaoning) Biotech Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of 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
Cerebral Ischemia, Cerebral Atherosclerosis
What is being tested?
Drug eluting balloon (Vmoky)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteChina
Study dates
21 Jun 2021to 30 Nov 2023
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80 years old；
  • Symptomatic intracranial artery stenosis, the degree of intracranial diseased artery vascular stenosis measured under cerebral angiography between 70~99% (WASID method)；
  • Symptoms are still recurrent after conservative medication (symptoms refer to stroke and transient ischemic episodes of the brain)，or intracranial artery stenosis combined with remote low perfusion performance (rCBF or rCBV abnormalities) in patients.
  • The stenotic vessels are located in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, distal blood vessels are normal；
  • Only one lesion needed to be treated；
  • The intracranial artery needed to be treated l art mm in diameter；
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  • Pre-expansion must be satisfied: forward blood flow TICI 3 level, pre-expanded guide wire retention, observation for 5 minutes, residual stenosis is still ≤50%; without blood limited dissection；
  • Patients have at least 1 porridge plaque risk factor, including past or existing hypertension, diabetes, hyperlipidemia, smoking;
  • mRS≤3 points；
  • Patients or their guardians are able to understand the purpose of the trial, voluntarily participate in and sign a written informed consent form, and receive follow-up visits from patients.

Who cannot join

  • Target lesion is in-stent restenosis；
  • Exist lesion stenosis more than 50% out of the target vessel；
  • Intracranial haemorrhage occurred within 3 months (substantial cerebral hemorrhage, large amount of subcranial hemorrhage, subdural/external bleeding)；
  • Acute ischemic stroke has occurred in the last two weeks；
  • Stenosis caused by non-atherosclerosis: e.g. arterial mezzanine, moya-moya disease, vasculitis, radioactive vascular disease or fibrous muscle dysplasia;
  • Severe calcified, angulate and Mori type C lesions, as well as congenital development of thin blood vessels and fenestration；
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  • Combine intracranial tumors, aneurysms, or intracranial venous malformations；
  • There are risk factors that can lead to cardiogenic embolism: fibrillation, left-ventricle thrombosis, mycardial infarction within 6 weeks, etc；
  • Uncontrollable hypertension by medication (Systolic pressure≥ystolic pres diastolic blood pressure≥pressurec；
  • Severe combined or unstable conditions, such as severe heart failure, lung failure or kidney failure (serum creatinine>3.0mg/dL (264 μmol/L) or renal cyspheric filtration rate (GFR) <30ml/min), severe liver insequencies, malignant tumors;
  • A history of gastrointestinal haemorrhage or haemorrhagic disease (e.g. idiopathic platelet reduction cyanosis, etc.) or a history of bleeding tendencies within 6 months prior to the signing of the informed consent；
  • Hemoglobin is below 90g/L, plateplates<90×109/L；
  • The International Standardized Rate (INR) >1.5, with unreal corrective bleeding factors；
  • Can not carry out antiplatelet/anticoagulant treatment, with anaesthetic and contrast agent contraindication;
  • The angiography shows that the vascular path is curly, and the device is difficult to reach the target position or to withdraw；
  • Patients known to be allergic to heparin, paclitaxel, contrast, aspirin and clopidogrel, anesthetics;
  • Life expectancy is less than 1 year；
  • Participants in other drug or device clinical trials that have not been completed；
  • A pregnant or lactating woman, or a person planning to become pregnant within one year；
  • Other conditions that the researchers consider patients are not suitable.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Evaluation of the Safety and Efficacy of Drug Eluting Balloon Catheter for the Treatment of Patients With Symptomatic Intracranial Atherosclerosis Stenosis

A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.

Read the detailed description

This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter (Vmoky) produced by Yinyi (Liaoning) Biotech Co., Ltd. for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.

Being tested
Drug eluting balloon (Vmoky)
Medical subject headings
Brain Ischemia, Intracranial Arteriosclerosis

What participants receive

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

  • Drug eluting balloon (Vmoky)Device

    Use Vmoky Drug Eluting Balloon to treat patients with symptomatic intracranial atherosclerosis stenosis

Study groups in NCT04821726
Study groupRoleWhat they receive
Drug eluting balloon (Vmoky)ExperimentalA paclitaxel eluting balloon produced by Yinyi (Liaoning) Biotech Co., Ltd. Balloon length: 8-40 mm, diameter：1.25-5.00 mm.
Receives: Device: Drug eluting balloon (Vmoky)

What is being measured

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

  1. Restenosis

    Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss.

    Measured: 6 months (+60 days)

Secondary outcomes (11)

  1. Angiographic success rate

    TICI 3 blood flow, residual stenosis no more than 50% after 5 minutes and no flow-limited dissection

    Measured: immediately after procedure

  2. The success rate of device

    device successfully cross the lesion and inflate, post-procedural residual stenosis no more than 50%, no use of bail-out stent

    Measured: immediately after procedure

  3. The success rate of procedure

    Base on the device success, there is no stroke or death in-hospital

    Measured: In-hospital (Maximum 7 days after procedure)

  4. Target lesion stenosis

    Calculate the stenosis degree with Quantitative Coronary Angiography (QCA) method

    Measured: 6 months (+60 days) and 12 months (±60 days)

  5. Restenosis

    Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss.

    Measured: 12 months (±60 days)

  6. Stroke events

    Number of participants that occur these events

    Measured: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)

  7. Ischemic stroke and transient ischemic attack (TIA) in the area of the responsible blood vessels

    Number of participants that occur these events

    Measured: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)

  8. Ischemic stroke and transient ischemic attack (TIA) out of the area of the responsible blood vessels

    Number of participants that occur these events

    Measured: 30 days (±7 days), 6 months (±60 days), 12 months (±60 days)

  9. Non-stroke bleeding

    Number of participants that occur this event

    Measured: 12 months (±60 days)

  10. Mortality

    Number of participants that occur this event

    Measured: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)

  11. Serious adverse events and adverse events

    Number of participants that occur these events

    Measured: 12 months (±60 days)

Timeline

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

  1. First posted29 Mar 2021
  2. Study start21 Jun 2021
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

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
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04821726
Sponsor's protocol ID
LNYY2020001
Status last verified
Jan 2023
First submitted
14 Mar 2021
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Drug eluting balloon (Vmoky) in people with Cerebral Ischemia and Cerebral Atherosclerosis, run by Yinyi(Liaoning) Biotech Co., Ltd. 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 10 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?

Results are not available in the source record.

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?

Restenosis (time frame: 6 months (+60 days)). 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 NCT04821726.

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 31 Jan 2023.

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