A Single-Arm Trial of Neurovascular Drug-Eluting Balloon Dilatation Catheter Treating Symptomatic Intracranial Atherosclerotic Stenosis

Intracranial Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04949880
• Other study ID #: ZYLOX34202105
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: May 2023

Study information

• Verified date: October 2022
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a trial designed to test the efficacy and safety of the Neurovascular Drug-Eluting Balloon Dilatation Catheter.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

Intervention

Device:
• Neurovascular 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.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	Cangzhou Central hospital	Cangzhou	Hebei
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of USTC	Hefei	Anhui
China	Linyi People's Hospital	Linyi	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Changhai Hospital of Shanghai	Shanghai
China	General Hospital of Northen Theater Command	Shenyang	Liaoning
China	Wuhan Hospital of Traditional Chinese and Western Medicine	Wuhan	Hubei
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of device deficiency	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.	within 180+60 days
Other	Incidence of stroke events	Stroke events include hemorrhagic or ischemic stroke, transient cerebral ischemia.	7 days or at discharge / 30±7 days / 180+60 days
Other	Rate of death	Subjects who died from any cause would be counted.	7 days or at discharge / 30±7 days / 180+60 days
Other	The rate of AE	The definition of AE (Adverse Event) refers to ISO 14155.	within 180+60 days
Other	The rate of SAE	The definition of SAE (Serious Adverse Event) refers to ISO 14155.	within 180+60 days
Primary	Restenosis rate of the target lesion	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.	180+60 days
Secondary	Average stenosis degree of the target lesion	Subjects receive DSA / CTA examination in 180 days.	180+60 days
Secondary	Success rate of device	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.	Intraoperation
Secondary	Success rate of surgery	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.	Intraoperation