A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis
- Conditions
- Intracranial Atherosclerosis
- Interventions
- Device: Neurovascular Drug-Eluting Balloon Dilatation Catheter
- Registration Number
- NCT04949880
- Lead Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A Neurovascular Drug-Eluting Balloon Dilatation Catheter Neurovascular Drug-Eluting Balloon Dilatation Catheter
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (11)
The First Affiliated Hospital of USTC
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Cangzhou Central hospital
🇨🇳Cangzhou, Hebei, China
Wuhan Hospital of Traditional Chinese and Western Medicine
🇨🇳Wuhan, Hubei, China
General Hospital of Northen Theater Command
🇨🇳Shenyang, Liaoning, China
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, China