Clinical trial NCT02197559: Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Official title: A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 168
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of stenosis: \>70% and \<99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol, but must be confirmed by catheter angiography for enrollment in the trial. All the patients should be performed with PTAS beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is willing and able to return for all follow-up visits required by the protocol Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.

Brief summary: The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting

Detailed description: The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now.

The main aim of this study is to observe the following details:

1. Late loss in lumen diameter in follow-up ≥50%
2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs

Secondary endpoint:

brain, gastrointestinal and urinary system bleeding in 12 months follow-up

Eligibility criteria: Inclusion Criteria:

- symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.

70% to 99% stenosis of vertebral artery ostium.

Exclusion Criteria:

* etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium

Primary outcomes:
measure: Late loss in lumen diameter in follow-up ≥50%
timeFrame: 1 year
measure: Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
timeFrame: 30 days
measure: Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
timeFrame: 12 months
Secondary outcomes:
measure: brain, gastrointestinal and urinary system bleeding in 12 months follow-up
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of neurosurgery, Xuanwu hospital
Study officials:
affiliation: Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
name: Feng Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References: