Vertebral Artery Origin Stenosis
Conditions
Keywords
vertebral artery origin stenosis, drug-coated balloon, stenting, medical treatment
Brief summary
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.
Interventions
DEVICEdrug-coated balloon
Orchid and Dahlia DCB
DEVICEbare metal stent
any type of bare metal stent
Sponsors
Chinese Society of Interventional Radiology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. aged between 18 and 80 years old; 2. TIA or non-disabling ischaemic stroke of the posterior circulation; 3. symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication 4. stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography; 5. NIHSS≤ 6; 6. score on the modified Rankin scale ≤ 3.
Exclusion criteria
1. Active bleeding or coagulation disorders or severe renal/liver impairment 2. allergy to iodinated contrast agent or related medicines; 3. acute stroke in 3 weeks 4. more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm) 5. a potential cause of stenosis other than atherosclerosis 6. Severe stenosis was found in the anterior circulation artery(\>70%) 7. intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days; 8. ISR patients; 9. Severe calcification lesion； 10. obvious thrombosis in vessel; 11. pregnancy; 12. a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months | 12 months | vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lumen loss at 12 months | 12 months | lumen loss measured by doppler untrasound |
| restenosis at 6 months | 6 months | restenosis was assessed by doppler untrasound |
| restenosis at 12 months | 12 months | restenosis was assessed by doppler untrasound |
| lumen loss at 6 months | 6 months | lumen loss measured by doppler untrasound |
| Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days | 30 days | safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke diagnosed by investigators within 30 days after start of the treatment |
| stent fracture rate at 12 months | 12 months | stent fracture was assessed by DSA |
| traget lesion revascularizition at 12 months | 12 months | traget lesion revascularizition including envascular intervention and Surgery |
Countries
China
Outcome results
None listed