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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB group | Experimental | use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-coated balloon catheter(Orchid, Acotec) | Procedure | After predilation, using drug-coated balloon catheter to cover the whole treated segment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liqun Jiao, PhD | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41067866 | Derived | 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. 2026 Mar;21(3):362-371. doi: 10.1177/17474930251377055. Epub 2025 Oct 9. | |
| 33584491 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Intracranial artery stent system(APOLLO) | Procedure | stent assisted angioplasty |
|
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 |
| 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |