Clinical trial NCT04821726: DEB for Symptomatic Intracranial Atherosclerosis Stenosis
Official title: Evaluation of the Safety and Efficacy of Drug Eluting Balloon Catheter for the Treatment of Patients With Symptomatic Intracranial Atherosclerosis Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Ischemia
Cerebral Atherosclerosis
Lead sponsor: Yinyi(Liaoning) Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Henan Provincial People's Hospital
First posted: 2021-03-29
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 80 years old；
2. Symptomatic intracranial artery stenosis, the degree of intracranial diseased artery vascular stenosis measured under cerebral angiography between 70\~99% (WASID method)；
3. 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.
4. 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；
5. Only one lesion needed to be treated；
6. The intracranial artery needed to be treated l art mm in diameter；
7. 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；
8. Patients have at least 1 porridge plaque risk factor, including past or existing hypertension, diabetes, hyperlipidemia, smoking;
9. mRS≤3 points；
10. 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.

Exclusion Criteria:

1. Target lesion is in-stent restenosis；
2. Exist lesion stenosis more than 50% out of the target vessel；
3. Intracranial haemorrhage occurred within 3 months (substantial cerebral hemorrhage, large amount of subcranial hemorrhage, subdural/external bleeding)；
4. Acute ischemic stroke has occurred in the last two weeks；
5. Stenosis caused by non-atherosclerosis: e.g. arterial mezzanine, moya-moya disease, vasculitis, radioactive vascular disease or fibrous muscle dysplasia;
6. Severe calcified, angulate and Mori type C lesions, as well as congenital development of thin blood vessels and fenestration；
7. Combine intracranial tumors, aneurysms, or intracranial venous malformations；
8. There are risk factors that can lead to cardiogenic embolism: fibrillation, left-ventricle thrombosis, mycardial infarction within 6 weeks, etc；
9. Uncontrollable hypertension by medication (Systolic pressure≥ystolic pres diastolic blood pressure≥pressurec；
10. 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;
11. 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；
12. Hemoglobin is below 90g/L, plateplates\<90×109/L；
13. The International Standardized Rate (INR) \>1.5, with unreal corrective bleeding factors；
14. Can not carry out antiplatelet/anticoagulant treatment, with anaesthetic and contrast agent contraindication;
15. The angiography shows that the vascular path is curly, and the device is difficult to reach the target position or to withdraw；
16. Patients known to be allergic to heparin, paclitaxel, contrast, aspirin and clopidogrel, anesthetics;
17. Life expectancy is less than 1 year；
18. Participants in other drug or device clinical trials that have not been completed；
19. A pregnant or lactating woman, or a person planning to become pregnant within one year；
20. Other conditions that the researchers consider patients are not suitable.

Primary outcomes:
measure: Restenosis
timeFrame: 6 months (+60 days)
Secondary outcomes:
measure: Angiographic success rate
timeFrame: immediately after procedure
measure: The success rate of device
timeFrame: immediately after procedure
measure: The success rate of procedure
timeFrame: In-hospital (Maximum 7 days after procedure)
measure: Target lesion stenosis
timeFrame: 6 months (+60 days) and 12 months (±60 days)
measure: Restenosis
timeFrame: 12 months (±60 days)
measure: Stroke events
timeFrame: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
measure: Ischemic stroke and transient ischemic attack (TIA) in the area of the responsible blood vessels
timeFrame: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
measure: Ischemic stroke and transient ischemic attack (TIA) out of the area of the responsible blood vessels
timeFrame: 30 days (±7 days), 6 months (±60 days), 12 months (±60 days)
measure: Non-stroke bleeding
timeFrame: 12 months (±60 days)
measure: Mortality
timeFrame: 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
measure: Serious adverse events and adverse events
timeFrame: 12 months (±60 days)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital
name: Tianxiao Li
role: PRINCIPAL_INVESTIGATOR
References: