AcoArt VI / Vertebral Artery Ostium Stenosis in China

Not Applicable

Completed

• Conditions: Transient Ischemic Attack; Ischemic Stroke
• Interventions: Procedure: drug-coated balloon catheter（Orchid, Acotec）; Procedure: Intracranial artery stent system（APOLLO）

• Registration Number: NCT03910166
• Lead Sponsor: Acotec Scientific Co., Ltd

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Study Start: 2020-01-06
• Primary Completion: 2023-07-07
• Study Completion: 2023-10-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• aged between 18 and 80 years old
• symptomatic VAO stenosis refractory to AMM (aggressive medical management)
• etiology of VAOS was atherosclerosis
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCB group	drug-coated balloon catheter（Orchid, Acotec）	use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm
BMS group	Intracranial artery stent system（APOLLO）	use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group

Primary Outcome Measures

Name	Time	Method
Rate of device success	during the operation	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.
Rate of target lesion restenosis	12Months	Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months

Secondary Outcome Measures

Name	Time	Method
Rate of device success	during the operation	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.
Incidence of transient ischemic attack of posterior circulation	12 Months	incidence of transient ischemic attack of posterior circulation within 12 months
Incidence of hemorrhagic stroke and posterior circulation ischemic stroke	12 Months	incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months

Trial Locations

Locations (1)

Xuanwu hospital; 🇨🇳 Beijing, China