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

NCT02197559 | Completed DMC

• 1 other identifier: BEST-VAOS
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents

Outcome Measures

Primary Outcomes (3)

• Late loss in lumen diameter in follow-up ≥50%

  Late loss in lumen diameter in follow-up ≥50%

  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

  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

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (1)

BMS group, DES group

All the participants in this group will be performed with bare-metal stents or drug -eluting stents

Procedure: DES group; Procedure: BMS group

Interventions

DES group PROCEDURE

all the participants in this group will be performed with drug -eluting stents

Also known as: Drug -eluting stents group

BMS group, DES group

BMS group PROCEDURE

all the participants in this group will be performed with bare-metal stents

Also known as: Bare-metal stents group

BMS group, DES group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium.
• % to 99% stenosis of vertebral artery ostium.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Department of neurosurgery, Xuanwu hospital

Beijing, 100053, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feng Ling, M.D.

  Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2014
• First Posted: July 22, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 24, 2016

Record last verified: 2014-07

Locations

CN (1)