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

Yinyi(Liaoning) Biotech Co., Ltd.1 site in 1 country155 target enrollmentJune 21, 2021

ConditionsCerebral Ischemia Cerebral Atherosclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebral Ischemia
Sponsor: Yinyi(Liaoning) Biotech Co., Ltd.
Enrollment: 155
Locations: 1
Primary Endpoint: Restenosis
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 21, 2021

End Date

November 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yinyi(Liaoning) Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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；
•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.

Exclusion Criteria

•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；
•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;

Outcomes

Primary Outcomes

Restenosis

Time Frame: 6 months (+60 days)

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.

Secondary Outcomes

The success rate of device(immediately after procedure)
Target lesion stenosis(6 months (+60 days) and 12 months (±60 days))
Restenosis(12 months (±60 days))
Ischemic stroke and transient ischemic attack (TIA) out of the area of the responsible blood vessels(30 days (±7 days), 6 months (±60 days), 12 months (±60 days))
Stroke 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(30 days (±7 days), 6 months (±60 days) and 12 months (±60 days))
Angiographic success rate(immediately after procedure)
The success rate of procedure(In-hospital (Maximum 7 days after procedure))
Non-stroke bleeding(12 months (±60 days))
Mortality(30 days (±7 days), 6 months (±60 days) and 12 months (±60 days))
Serious adverse events and adverse events(12 months (±60 days))