DEB for Symptomatic Intracranial Atherosclerosis Stenosis

NCT ID: NCT04821726

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-21
• Study Completion Date: 2023-11-30

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.

Conditions

Cerebral Ischemia; Cerebral Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug eluting balloon (Vmoky)

A paclitaxel eluting balloon produced by Yinyi (Liaoning) Biotech Co., Ltd. Balloon length: 8-40 mm, diameter：1.25-5.00 mm.

Group Type: EXPERIMENTAL

Drug eluting balloon (Vmoky)

Intervention Type: DEVICE

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

Interventions

Drug eluting balloon (Vmoky)

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Yinyi(Liaoning) Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tianxiao Li

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial People's Hospital

Locations

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

LNYY2020001

Identifier Type: -

Identifier Source: org_study_id