An observational study in Ischemic Stroke, sponsored by Xuanwu Hospital, Beijing. Completed at 1 site in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-24.
Sponsored by Xuanwu Hospital, Beijing · Observational
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting
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:
Secondary endpoint:
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
2,593 studies on the registry are indexed under Ischemic Stroke; 931 are open to participants now.
This study's enrollment of 168 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
70% to 99% stenosis of vertebral artery ostium.
Exclusion Criteria:
All the participants in this group will be performed with bare-metal stents or drug -eluting stents
Procedure: DES group · Procedure: BMS group
all the participants in this group will be performed with drug -eluting stents
Also known as: Drug -eluting stents group
all the participants in this group will be performed with bare-metal stents
Also known as: Bare-metal stents group
Late loss in lumen diameter in follow-up ≥50%
Late loss in lumen diameter in follow-up ≥50%
Time frame: 1 year
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Time frame: 30 days
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Time frame: 12 months
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
brain, gastrointestinal and urinary system bleeding in 12 months follow-up
Time frame: 12 months
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing