Clinical trial NCT03311360: Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
Official title: Chinese Society of Interventional Radiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Artery Origin Stenosis
Keywords: vertebral artery origin stenosis
drug-coated balloon
stenting
medical treatment
Lead sponsor: Chinese Society of Interventional Radiology
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients meet all of the inclusion criteria and none of the excusion criteria

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 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.

Primary outcomes:
measure: Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months
timeFrame: 12 months
Secondary outcomes:
measure: lumen loss at 6 months
timeFrame: 6 months
measure: lumen loss at 12 months
timeFrame: 12 months
measure: restenosis at 6 months
timeFrame: 6 months
measure: restenosis at 12 months
timeFrame: 12 months
measure: traget lesion revascularizition at 12 months
timeFrame: 12 months
measure: Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days
timeFrame: 30 days
measure: stent fracture rate at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen hospital
city: Beijing
country: China
facility: The rockets army general hospital
city: Dalian
country: China
facility: The first affiliated hospital of Dalian medical university
city: Harbin
country: China
facility: The first affiliated hospital of Harbin medical university
city: Jilin
country: China
facility: The first hospital of Jilin university
city: Shenyang
country: China
facility: Shengjing Hosptal of china medical university
city: Zhengzhou
country: China
facility: Henan provincial peoples hospital
city: Zhengzhou
country: China
facility: The first hospital of zhengzhou university
city: Zhengzhou
country: China
facility: Zhengzhou center hospital
Study officials:
References: