Vertebral Artery Origin Stenosis Clinical Trial
Official title:
Chinese Society of Interventional Radiology
| NCT number | NCT03311360 |
| Other study ID # | CSIR01 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2018 |
| Est. completion date | October 1, 2020 |
| Verified date | January 2019 |
| Source | Chinese Society of Interventional Radiology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 95 |
| Est. completion date | October 1, 2020 |
| Est. primary completion date | February 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Anzhen hospital | Beijing | |
| China | The rockets army general hospital | Beijing | |
| China | The first affiliated hospital of Dalian medical university | Dalian | |
| China | The first affiliated hospital of Harbin medical university | Harbin | |
| China | The first hospital of Jilin university | Jilin | |
| China | Shengjing Hosptal of china medical university | Shenyang | |
| China | Henan provincial peoples hospital | Zhengzhou | |
| China | The first hospital of zhengzhou university | Zhengzhou | |
| China | Zhengzhou center hospital | Zhengzhou |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese Society of Interventional Radiology |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months | vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician | 12 months | |
| Secondary | lumen loss at 6 months | lumen loss measured by doppler untrasound | 6 months | |
| Secondary | lumen loss at 12 months | lumen loss measured by doppler untrasound | 12 months | |
| Secondary | restenosis at 6 months | restenosis was assessed by doppler untrasound | 6 months | |
| Secondary | restenosis at 12 months | restenosis was assessed by doppler untrasound | 12 months | |
| Secondary | traget lesion revascularizition at 12 months | traget lesion revascularizition including envascular intervention and Surgery | 12 months | |
| Secondary | Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 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 | 30 days | |
| Secondary | stent fracture rate at 12 months | stent fracture was assessed by DSA | 12 months |