Intracranial Atherosclerosis
Conditions
Brief summary
This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.
Detailed description
This is a prospective multicentre single-arm trial conducted by 11 centers in mainland China. Approximately 132 subjects with symptomatic intracranial atherosclerotic stenosis receive endovascular treatment using the neurovascular drug-eluting balloon dilatation catheter designed by Zylox.
Interventions
DEVICENeurovascular Drug-Eluting Balloon Dilatation Catheter
The neurovascular drug-eluting balloon dilatation catheter consists of a tip, a drug-coated balloon, markers, a catheter and a catheter hub. The main component of the drug coating is sirolimus, and the coating is evenly distributed on the effective length surface of the balloon.
Sponsors
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 80 years, any gender; * Subject has symptomatic intracranial atherosclerotic stenosis that the degree of the artery stenosis is between 70% and 99% diagnosed by intracranial angiography; * The target stenotic artery locates in Internal Carotid Artery (intracranial segment), Middle Cerebral Artery (M1, M2), Basilar Artery, Vertebral Artery (intracranial segment); * Intracranial artery stenosis requiring interventional treatment is a single lesion; * Subject has at least two atherosclerosis risk factors including history or present hypertension, diabetes, hyperlipidemia, smoking, age\>45; * modified Rankin Scale(mRS) score≤2 before enrollment; * Subject or guardian is able to understand the purpose of study, agree to provide follow-up data and has provided written informed consent.
Exclusion criteria
* History of acute ischemic stroke within 2 weeks; * History of intracranial hemorrhage (including intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage and epidural hemorrhage) within 3 months; * Hypertension uncontrolled by medicine (Systolic pressure≥180 mmHg or diastolic pressure≥110 mmHg continuously); * Combined with the intracranial tumor, aneurysm or intracranial arteriovenous malformation; * The length of intracranial artery stenosis \>10mm and extremely angulated \>90°, which indicated by angiography; * History of stent intervention within the target lesion; * Allergic to heparin, sirolimus (i.e. rapamycin), contrast agents, aspirin, clopidogrel, anesthetics; * History of gastrointestinal hemorrhage within 6 months before signing the informed consent form, which is unable to receive antiplatelet therapy; * Platelet (PLT)\<90\*10\^9/L; * Creatinine\>250 umol/L; * International Normalized Ratio (INR)\>1.5; * Female subject who is pregnant or breast-feeding, or who has a pregnancy plan within 12 months; * Expected life \<12 months; * Unable to cooperate with or tolerate the interventional surgery; * Subject who has participated in other drug or device clinical trials or hasn't reached the primary end point; * Angiography indicates intracranial artery stenosis caused by arterial dissection, arteritis, and thrombosis; * Angiography indicates the vascular path is tortuous, the experimental device is difficult to reach the target position or be retracted; * Other circumstances judged by researchers that are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restenosis rate of the target lesion | 180+60 days | Subjects receive Digital Subtraction Angiography (DSA) / Computed Tomography Angiography (CTA) examination in 180 days to analyze whether the degree of stenosis is greater than or equal to 50%, if so, the target lesion restenosis happens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average stenosis degree of the target lesion | 180+60 days | Subjects receive DSA / CTA examination in 180 days. |
| Success rate of device | Intraoperation | After receiving DSA examination, success rate of device is defined as experimental device-neurovascular drug-eluting balloon dilatation catheter advanced on position successfully, balloon retracted smoothly after expanded, without balloon rupture and balloon catheter break, etc. |
| Success rate of surgery | Intraoperation | After receiving DSA examination, success rate of surgery is defined as the final residual stenosis degree of target lesion\<50% and modified thrombolysis in cerebral infarction score (mTICI) 2b/3, whether or not other additional treatments are applied. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device deficiency | within 180+60 days | Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems, malfunctions, etc. |
| The rate of SAE | within 180+60 days | The definition of SAE (Serious Adverse Event) refers to ISO 14155. |
| Incidence of stroke events | 7 days or at discharge / 30±7 days / 180+60 days | Stroke events include hemorrhagic or ischemic stroke, transient cerebral ischemia. |
| Rate of death | 7 days or at discharge / 30±7 days / 180+60 days | Subjects who died from any cause would be counted. |
| The rate of AE | within 180+60 days | The definition of AE (Adverse Event) refers to ISO 14155. |
Countries
China
Outcome results
None listed