ACOART Intracranial de Novo:DCB in the Treatment of Symptomatic Intracranial Atherosclerotic de Novo Stenosis

Study Overview
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Brief Summary
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The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial de novo stenosis.

Detailed Description
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This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is angiographic restenosis at 6 months post-procedure.

Official Title
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A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intracranial Drug-coated Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic de Novo Stenosis

Conditions
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Intracranial Atherosclerosis, Stroke

Intervention / Treatment
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* Device: drug coated balloon
* Device: stent system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age; Patients with symptomatic intracranial atherosclerotic stenosis; Patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (DSA); Confirmed by DSA，the diameter of the target vessel is between 2.5mm-4.5mm ; according to WASID method, the degree of stenosis of the target lesion is 70%-99%; 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; Patients with stroke caused by perforating artery occlusion; Any history of brain parenchymal 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); The vascular path showed in angiography is so tortuous that it is difficult to advance catheters to the target lesion or retrieve; Lesions that investigators believe are not suitable for stenting; Patients with thrombus in target vessel; In addition to the target lesion, there are still other de novo lesion or ISR lesion with more than 70% diameter stenosis in intracranial arteries that need to be treated at the same time; After endovascular treatment of the target lesion, there is still a stenosis of more than 50% in the main blood supplying artery or an obstructive lesion in the distal vessel of target lesion; Major surgery (including open femoral artery, aortic or carotid artery surgery) within the past 30 days or planned within 90 days; Patients with renal artery, iliac artery, and coronary artery requiring simultaneous intervention; Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation; Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any Other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected Vasospasm, suspicious embolism recanalization, etc.; 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; Patients with myocardial infarction within 6 weeks before procedure; Those who cannot tolerate general anesthesia due to insufficiency of important organs such as heart and lungs; Patients with known severe hepatic and renal dysfunction; Patients with hemoglobin<100g/L, platelet count<100×1,000,000,000/L, INR>1.5 or there are uncorrectable factors leading to bleeding(if there are multiple checks, the last one shall prevail); Patients who cannot receive dual antiplatelet therapy due to existing diseases or are tolerant to dual antiplatelet therapy confirmed by relevant test; Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs; Current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg); Life expectancy <1 year; Pregnant or lactating women; Patients who cannot complete the follow-up due to cognitive, emotional or mental illness; Patients who are participating in other drug/device clinical trials and have not completed all follow-ups required by the programmer; According to the judgement of the investigator, other situations that are not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB group<br>use intracranial drug coated balloon catheter made by Acotec Scientific Co.,Ltd. | Device: drug coated balloon<br>* paclitaxel coated balloon catheter for intracranial PTA treatment<br>|
| Active Comparator: Stent group<br>use the Intracranial Stent System made by MicroPort. | Device: stent system<br>* The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic restenosis of the target lesion | angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab | 6 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device success rate | DCB: The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated. Stent: The stent enables successful arrival of the lesion and subsequent release of the stent delivery system for successful withdrawal. | during procedure | 
| target vessel stroke or death event | Stroke (bleeding and ischemia) or death related to target vessels within 30 days postoperatively. | within 30 days post-procedure | 
| target vessel ischemia stroke event | The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively | between 31 days and 6 months post-procedure | 
| Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events | Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively | between 31 days and 6 months post-procedure | 
| target vessel death event | Target-vessel related death 31 days to 6 months postoperatively | between 31 days and 6 months post-procedure | 
| transient ischemic attack event | transient ischemic attack event transient ischemic attack event | at 6 months post-procedure | 
| National Institutes of Health Stroke Scale score | National Institutes of Health Stroke Scale score at 6 months post-procedure(0-42,higher scores mean a worse outcome) | at 6 months post-procedure | 
| Modified Rankin Scale score | Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome) | at 6 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Atherosclerosis, Stroke, drug coated balloon