Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis

Recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • DES group Procedure
    Other Names: Drug -eluting stents group
    Intervention Desc: all the participants in this group will be performed with drug -eluting stents
    ARM 1: Kind: Experimental
    Label: BMS group, DES group
    Description: All the participants in this group will be performed with bare-metal stents or drug -eluting stents
  • BMS group Procedure
    Other Names: Bare-metal stents group
    Intervention Desc: all the participants in this group will be performed with bare-metal stents
    ARM 1: Kind: Experimental
    Label: BMS group, DES group
    Description: All the participants in this group will be performed with bare-metal stents or drug -eluting stents

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Late loss in lumen diameter in follow-up ≥50% 1 year Yes
Primary Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs 30 days Yes
Primary Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs 12 months Yes
Secondary brain, gastrointestinal and urinary system bleeding in 12 months follow-up 12 months Yes

Sponsors