AcoArt VI / Vertebral Artery Ostium Stenosis in China

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis

Detailed Description
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Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis . DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Official Title
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Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis

Conditions
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Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Procedure: drug-coated balloon catheter（Orchid, Acotec）
* Procedure: Intracranial artery stent system（APOLLO）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 80 years old symptomatic VAO stenosis refractory to best medical treatment the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm,Target lesion has stenosis ≥ 70% evidenced by angiography Score on the modified Rankin scale ≤ 3 NIHSS≤ 6 Patients have signed informed consent Exclusion Criteria: In-stent restenosis in vertebral artery Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection Tortuous or variable vessels distal serial stenosis or distal vascular dysplasia of the stenosis segment Non-atherosclerotic arterial stenosis Non-vertebral artery stenosis caused TIA or stroke intracranial stent implantation within 12 months Intracranial hemorrhage occurred within 3 months Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure Active bleeding or coagulation disorders Serious liver/kidney damage, not suitable for routine surgical treatment Myocardial infarction or extensive cerebral infarction occurred within 2 weeks Uncontrolled high blood pressure Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc Life expectancy shorter than 1 years Patients whit cognitive impairment or mental disorders Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc Pregnant and lactating women Patients who have participated in other clinical trials during the same period that lead to researchers who believe that patients may not be able to follow the trial program

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 DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm | Procedure: drug-coated balloon catheter（Orchid, Acotec）<br>* After predilation, using drug-coated balloon catheter to cover the whole treated segment<br>|
| Active Comparator: BMS group<br>use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group | Procedure: Intracranial artery stent system（APOLLO）<br>* stent assisted angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion restenosis rate | Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months | 12Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device success rate | DEB group:DEB catheter can reach the target lesions, expand as expected(not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred. | during the operation | 
| incidence of hemorrhagic stroke and posterior circulation ischemic stroke | incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months | 12 Months | 
| incidence of transient ischemic attack of posterior circulation | incidence of transient ischemic attack of posterior circulation within 12 months | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon catheter, stenting