AcoArt VI / Vertebral Artery Ostium Stenosis in China

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ischemic Stroke; Transient Ischemic Attack
• Intervention / Treatment: Procedure: drug-coated balloon catheter（Orchid, Acotec）; Procedure: Intracranial artery stent system（APOLLO）

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liqun Jiao; Phone Number: 13911224991; Email: DOCTOR_K@163.com

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB group; 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）; After predilation, using drug-coated balloon catheter to cover the whole treated segment
Active Comparator: BMS group; 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）; stent assisted angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of target lesion restenosis	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
Rate of device success	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of device success	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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Study Chair: Liqun Jiao, PhD, Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• Wang Y, Ma Y, Gao P, Chen Y, Yang B, Feng Y, Jiao L. Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jan 18;11:579238. doi: 10.3389/fneur.2020.579238. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): July 6, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: stenting; drug eluting balloon catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: Acotec-06

Drug and device information, study documents

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