DEB for Symptomatic Intracranial Atherosclerosis Stenosis

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Ischemia; Cerebral Atherosclerosis
• Intervention / Treatment: Device: Drug eluting balloon (Vmoky)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyue Hua; Phone Number: +8618624429311; Email: huaxy@dlyinyi.com
• Study Contact Backup: Name: Xiaoxue Bi; Phone Number: +8613842679897; Email: bixx@dlyinyi.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Tianxiao Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Drug eluting balloon (Vmoky); Use Vmoky Drug Eluting Balloon to treat patients with symptomatic intracranial atherosclerosis stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months (+60 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic success rate	TICI 3 blood flow, residual stenosis no more than 50% after 5 minutes and no flow-limited dissection	immediately after procedure
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	immediately after procedure
The success rate of procedure	Base on the device success, there is no stroke or death in-hospital	In-hospital (Maximum 7 days after procedure)
Target lesion stenosis	Calculate the stenosis degree with Quantitative Coronary Angiography (QCA) method	6 months (+60 days) and 12 months (±60 days)
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.	12 months (±60 days)
Stroke events	Number of participants that occur these events	30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
Ischemic stroke and transient ischemic attack (TIA) in the area of the responsible blood vessels	Number of participants that occur these events	30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
Ischemic stroke and transient ischemic attack (TIA) out of the area of the responsible blood vessels	Number of participants that occur these events	30 days (±7 days), 6 months (±60 days), 12 months (±60 days)
Non-stroke bleeding	Number of participants that occur this event	12 months (±60 days)
Mortality	Number of participants that occur this event	30 days (±7 days), 6 months (±60 days) and 12 months (±60 days)
Serious adverse events and adverse events	Number of participants that occur these events	12 months (±60 days)

Collaborators and Investigators

• Sponsor: Yinyi(Liaoning) Biotech Co., Ltd.
• Collaborators: Henan Provincial People's Hospital
• Investigators: Principal Investigator: Tianxiao Li, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: March 14, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Infarction; Stroke; Brain Infarction; Intracranial Arterial Diseases; Brain Ischemia; Ischemia; Cerebral Infarction; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: LNYY2020001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No