Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study

Chinese Society of Interventional Radiology

Status: Completed

Conditions: Vertebral Artery Origin Stenosis

Treatments: Device: bare metal stent; Device: drug-coated balloon

Study type: Observational

Funder types: Other

Identifiers

NCT03311360

CSIR01

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

95 participants in 2 patient groups

drug-coated balloon

Description:

patients with vertebral artery origin stenosis treated with drug-coated balloons

Treatment:

Device: drug-coated balloon

bare metal stent

Description:

patients with vertebral artery origin stenosis treated with bare metal stent

Treatment:

Device: bare metal stent