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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Vertebral Artery Origin Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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drug-coated balloon

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

drug-coated balloon

Intervention Type DEVICE

Orchid and Dahlia DCB

bare metal stent

patients with vertebral artery origin stenosis treated with bare metal stent

bare metal stent

Intervention Type DEVICE

any type of bare metal stent

Interventions

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drug-coated balloon

Orchid and Dahlia DCB

Intervention Type DEVICE

bare metal stent

any type of bare metal stent

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No