CompletedNot Applicable

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

China95 participantsStarted 2018-01-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months

Timeframe: 12 months

Trial details

NCT IDNCT03311360

SponsorChinese Society of Interventional Radiology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-02-01

View on ClinicalTrials.gov More Vertebral Artery Origin Stenosis trials