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
| Registry | NCT03910166 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 180 (Actual) |
| Sponsor | Acotec Scientific Co., Ltd (Industry) |
| Conditions | Ischemic Stroke, Transient Ischemic Attack |
| Interventions | drug-coated balloon catheter（Orchid, Acotec）, Intracranial artery stent system（APOLLO） (Procedure) |
| Dates | start 2020-01-06, primary completion 2023-07-07, completion 2023-10-01, first posted 2019-04-10, last updated 2024-08-01 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Ischemic Stroke All trials for Transient Ischemic Attack All trials of drug-coated balloon catheter（Orchid, Acotec） All trials of Intracranial artery stent system（APOLLO）
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DCB group | Experimental | Procedure: 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 | Active comparator | Procedure: 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 |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Xuanwu hospital | Beijing | China |