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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Atherosclerosis
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Neurovascular Drug-Eluting Balloon Dilatation Catheter	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average stenosis degree of the target lesion	Subjects receive DSA / CTA examination in 180 days.	180+60 days
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Rate of death	Subjects who died from any cause would be counted.	7 days or at discharge / 30±7 days / 180+60 days
The rate of AE	The definition of AE (Adverse Event) refers to ISO 14155.	within 180+60 days
The rate of SAE	The definition of SAE (Serious Adverse Event) refers to ISO 14155.	within 180+60 days

Collaborators and Investigators

• Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (ACTUAL): July 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: ZYLOX34202105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No