AcoArt VI / Vertebral Artery Ostium Stenosis in China

NCT03910166 | Completed

• 1 other identifier: Acotec-06
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke; Transient Ischemic Attack

Keywords

drug eluting balloon catheter; stenting

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Rate of device success

  during the operation

• Incidence of hemorrhagic stroke and posterior circulation ischemic stroke

  12 Months

• Incidence of transient ischemic attack of posterior circulation

  12 Months

Study Arms (2)

DCB group

EXPERIMENTAL

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）

BMS group

ACTIVE COMPARATOR

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）

Interventions

drug-coated balloon catheter（Orchid, Acotec） PROCEDURE

After predilation, using drug-coated balloon catheter to cover the whole treated segment

DCB group

Intracranial artery stent system（APOLLO） PROCEDURE

stent assisted angioplasty

BMS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead

Study Sites (1)

Xuanwu hospital

Beijing, China

Location

Related Publications (2)

• Luo J, Jiang C, Wang H, Peng R, Wang T, Kuai D, Liang G, Wang F, Wang S, Xu C, Chen W, Deng J, Hu X, Wan S, Li B, Yin B, Du Y, Cheng G, Wan J, Chen X, Wang Y, Jiao L; DCB-VAOS Trial Investigators. Effect of drug-coated balloon in patients with severe vertebral artery origin stenosis: A multicenter randomized controlled trial. Int J Stroke. 2025 Oct 9:17474930251377055. doi: 10.1177/17474930251377055. Online ahead of print.

  PMID: 41067866 DERIVED

• 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.

  PMID: 33584491 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Liqun Jiao, PhD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 10, 2019
• Study Start: January 6, 2020
• Primary Completion: July 7, 2023
• Study Completion: October 1, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-01

Locations

CN (1)