A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis

Acotec Scientific Co., Ltd1 site in 1 country20 target enrollmentMay 26, 2021

ConditionsIntracranial Atherosclerosis Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Atherosclerosis
Sponsor: Acotec Scientific Co., Ltd
Enrollment: 20
Locations: 1
Primary Endpoint: Target vessel stroke or death event
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.

Detailed Description

This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.

Registry

clinicaltrials.gov

Start Date

May 26, 2021

End Date

December 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Acotec Scientific Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 to 80 years of age
•Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as \>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \>20% absolute luminal loss
•presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor
•asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and/or by an American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System score \<3 on DSA.
•the diameter of target vessel is 2.0-4.5mm
•there is only one intracranial ISR lesion per subject
•baseline mRS score ≤2
•Voluntarily participate in this study and sign the informed consent form

Exclusion Criteria

•Patients with stroke within 2 weeks before procedure;
•any history of brain parenchyma or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days.
•Those who have received thrombolysis within 24 hours before procedure;
•Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline)
•patients with thrombus in target vessels.
•in addition to ISR lesions, there are other primary intracranial lesions that need endovascular treatment.
•Major surgery (including open femoral, aortic or carotid artery surgery) is planned within the past 30 days or within 90 days.
•patients with renal artery, iliac artery and cardiac coronary artery requiring simultaneous intervention.
•Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations.
•Cardiac stroke or potential cardiogenic thromboembolism, with any of the following cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, spontaneous acoustic imaging of the left atrium;

Outcomes

Primary Outcomes

Target vessel stroke or death event

Time Frame: within 30 days post-procedure

Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.

Secondary Outcomes

Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events(between 31 days and 12 months post-procedure)
device success rate(assessed during procedure)
target vessel ischemia stroke event(between 31days and 12months post-procedure)
target vessel death event(between 31 days and 12 months post-procedure)
National Institutes of Health Stroke Scale score(at 12 months post-procedure)
Modified Rankin Score score(at 12 months post-procedure)