Status:
COMPLETED
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
Lead Sponsor:
Chinese Society of Interventional Radiology
Conditions:
Vertebral Artery Origin Stenosis
Eligibility:
All Genders
18-80 years
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.
Eligibility Criteria
Inclusion
- aged between 18 and 80 years old;
- TIA or non-disabling ischaemic stroke of the posterior circulation;
- symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
- stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
- NIHSS≤ 6;
- score on the modified Rankin scale ≤ 3.
Exclusion
- Active bleeding or coagulation disorders or severe renal/liver impairment
- allergy to iodinated contrast agent or related medicines;
- acute stroke in 3 weeks
- more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
- a potential cause of stenosis other than atherosclerosis
- Severe stenosis was found in the anterior circulation artery(\>70%)
- intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days;
- ISR patients;
- Severe calcification lesion；
- obvious thrombosis in vessel;
- pregnancy;
- a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT03311360
Start Date
January 1 2018
End Date
October 1 2020
Last Update
August 3 2021
Active Locations (9)
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1
Beijing Anzhen hospital
Beijing, China
2
The rockets army general hospital
Beijing, China
3
The first affiliated hospital of Dalian medical university
Dalian, China
4
The first affiliated hospital of Harbin medical university
Harbin, China