Phase
Condition
Stroke
Cerebral Ischemia
Treatment
POBA
DCB
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18 to 80 years old (including boundary value), gender is not limited;
The target lesion of the patient is a symptomatic intracranial atheroscleroticstenosis lesion (for part A only) or restenosis lesions after interventional therapy (for part B only);
Symptomatic intracranial arterial stenosis (intracranial segment of internal carotidartery (Petrous segment and above), middle cerebral artery, intracranial segment ofvertebral artery, basilar artery, etc.) within 6 months, the degree of stenosis ofthe diseased artery is between 70% and 99% (WASID method);
Patients with symptoms occurring more than once (symptoms refer to stroke ortransient ischemic attacks) after intensive drug therapy of internal medicine (including antiplatelet therapy, antihypertensive therapy, hypoglycemic therapy andlipid-lowering therapy);
The intracranial arterial stenosis lesion to be treated is a single lesion;
Patients with at least 1 risk factor for intracranial atherosclerotic plaque,including previous or existing hypertension, hyperlipidemia, diabetes, smoking;
Preoperative mRS ≤ 2, and NIHSS≤8;
Patients whose life expectancy is greater than 12 months as assessed by theinvestigator.
Patients or their guardians can understand the trial purpose, voluntarilyparticipate in and sign the informed consent form, and can accept follow-up visits.
Exclusion
Exclusion Criteria:
Severe calcification in the target vessel, severe distortion of the target vessel oranatomical factors that make it hard for interventional devices to be in place;
Ischemic symptoms are only associated with branch events;
Severe stenosis or occlusion of tandem extracranial or intracranial vessels at theproximal or distal end of the target vessel;
Angioplasty or stenting procedures is planned for extracranial vascular lesions withtandem intracranial vessels;
History of endarterectomy in the extracranial segment of carotid artery andvertebral artery within 30 days;
The target vessel has previously been treated with stenting or angioplasty or othermechanical devices (for Part A only);
Acute or subacute intraluminal thrombosis is found in the target vessel;
Patients with intracranial stenosis combined with aneurysm, intracranial tumor orintracranial vascular malformation, or intracranial arterial spasm withoutsignificant stenosis;
Intracranial hemorrhage (cerebral intraparenchymal hemorrhage, massive subarachnoidhemorrhage, and subdural/epidural hemorrhage) within 3 months;
There are cardiogenic stroke or risk factors that may contribute to cardioembolism,such as fibrillation, left ventricular thrombosis or myocardial infarction within 6weeks,;
Patients with abnormal coagulation function or bleeding tendency (e.g.,international normalized ratio (INR) > 1.5);
Patients with known hypersensitivity to iodine contrast medium, paclitaxel, oriopromide;
Patients who are participating in clinical trials of other drugs or devices;
Other conditions that the investigator deems the patient unsuitable for enrollment.
Study Design
Study Description
Connect with a study center
Xuanwu Hospital, Capital Medical University
Beijing, Beijing 100000
ChinaSite Not Available
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
ChinaSite Not Available
Nanyang Central Hospital
Nanyang, Henan
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin
ChinaSite Not Available
Jining First People's Hospital
Jining, Shandong
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University, School of Medicine
Shanghai, Shanghai
ChinaSite Not Available
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
ChinaSite Not Available
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaSite Not Available

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