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Completed

NCT Number: NCT00919165

Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement

To determine the effect of carotid artery stenting, on cognitive function, in patients with high grade carotid artery stenosis

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Key information

Conditions

Cognitive Function in Carotid Stenting Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

About this study

Single Center, Case Controlled design using pre and post stent cognitive function testin. Patients will serve as self controls to observe the effect, if any, of carotid stent placement on cognitive function in asymptomatic patients with high grade carotid artery stenosis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40-80 years of age
  • Right hand dominate
  • Asymptomatic:defined as: no symptoms of TIA/stroke in the previous 6 months
  • Baseline doppler study with a peak systolic velocity of 400cm/sec
  • Patient is deemed candidate for carotid artery stenting
  • TIMI flow of 1,2 or 3
  • 80% or greater stenosis of distal common or internal carotid artery, as determined angiographically, as defined in ACAS
  • Subjects are able to give informed consent
  • Subjects are willing/able to complete follow-up visits

Exclusion criteria

  • History of major stroke: within the past 6 months
  • History of Alzheimers disease or Dementia
  • Unable or willing to complete the baseline and 20 days neuro-cognitive testing planned major surgery within the next 2 months
  • Planned intervention opposite carotid artery within 2 months
  • Ineligibility for carotid stent procedure due to anatomy, thrombus, or inability to complete anti-platelet therapy
  • Any individual identified with cognitive impairment which would affect their performance during cognitive testing.

Treatment and study plan

Primary outcomes

  1. to determine the effect of carotid artery stenting, on cognitive function after carotid artery stenting in patients with severe carotid artery stenosis

    Time frame: 45 days

Secondary outcomes

  1. to evaluate the clinical benefit of carotid artery stenting on cognitive function, pre and post carotid artery stenting

    Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

Assessment of Cognitive Function in Patients Undergoing Carotid Artery Stent Placement: Cognitive Function in Carotid Stenting

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2009
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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