Ischemic Stroke, Transient Ischemic Attack
Conditions
Keywords
drug eluting balloon catheter, stenting
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.
Interventions
PROCEDUREdrug-coated balloon catheter（Orchid, Acotec）
After predilation, using drug-coated balloon catheter to cover the whole treated segment
PROCEDUREIntracranial artery stent system（APOLLO）
stent assisted angioplasty
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 hemorrhagic stroke and posterior circulation ischemic stroke | 12 Months | incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months |
| Incidence of transient ischemic attack of posterior circulation | 12 Months | incidence of transient ischemic attack of posterior circulation within 12 months |
Countries
China
Outcome results
None listed