Clinical trial NCT04949880: A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis
Official title: The Efficacy and Safety Study for Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis Using Neurovascular Drug-Eluting Balloon Dilatation Catheter: A Prospective Multicentre Single-arm Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Atherosclerosis
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Restenosis rate of the target lesion
timeFrame: 180+60 days
Secondary outcomes:
measure: Average stenosis degree of the target lesion
timeFrame: 180+60 days
measure: Success rate of device
timeFrame: Intraoperation
measure: Success rate of surgery
timeFrame: Intraoperation
Other outcomes:
measure: Incidence of device deficiency
timeFrame: within 180+60 days
measure: Incidence of stroke events
timeFrame: 7 days or at discharge / 30±7 days / 180+60 days
measure: Rate of death
timeFrame: 7 days or at discharge / 30±7 days / 180+60 days
measure: The rate of AE
timeFrame: within 180+60 days
measure: The rate of SAE
timeFrame: within 180+60 days
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Cangzhou
country: China
facility: Cangzhou Central hospital
state: Hebei
city: Wuhan
country: China
facility: Wuhan Hospital of Traditional Chinese and Western Medicine
state: Hubei
city: Shenyang
country: China
facility: General Hospital of Northen Theater Command
state: Liaoning
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital, Beijing
name: Liqun Jiao
role: PRINCIPAL_INVESTIGATOR
References: