NCTU
Newcastle Neurosurgery Clinical Trials Unit

Neurosurgical Clinical Trial Unit
Neurosurgical Clinical Trials - ICSS

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ICSS

ICSS

ICSS is an international, multicentre, randomised, controlled, open, prospective clinical trial evaluating primary stenting of carotid artery stenosis in patients with symptomatic disease in comparison to endarterectomy.

ICSS is a follow-on study to CAVATAS designed as an international, multicentre, randomised trial, which will evaluate stenting of carotid artery stenosis in patients with cerebrovascular disease.


Brief inclusion / exclusion criteria















Inclusion:

  • Symptomatic atheromatous carotid artery stenosis - suitable for both stenting and surgery
  • The severity of the stenosis should be at least 50% (as measured by NASCET method)
  • Symptoms must have occurred in the 12 months before randomisation
  • The patient must be clinically stable following their most recent symptoms
  • Investigator should be in equipoise regarding the two treatments for the enrolled patient
  • Patients must be willing to have either treatment, give consent and be willing to participate in follow-up
  • Patients must be able to undergo their allocated treatment as soon as possible after randomisation
  • Any age greater than 40 may be included. There is no upper age limit

    • Exclusion:

  • Patients refusing either treatment
  • Patients unable or unwilling to give informed consent
  • Patients unwilling or unable to participate in follow up for whatever reason
  • Patients who have had a major stroke with no useful recovery of function
  • Patients with a stenosis that is known to be unsuitable for stenting prior to randomisation
  • Patients not suitable for surgery due to anatomical factors
  • Patients with planned coronary artery bypass grafting or other major surgery in <1 month of treatment.
  • Carotid stenosis caused by non-atherosclerotic disease
  • Previous carotid endarterectomy or stenting in the randomised artery
  • Patients in who common carotid artery surgery is planned
  • Patients medically not fit for surgery
  • Patients who have a life expectancy of less than two years due to a pre-existing condition
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    Staff Involved

    Principal Investigators:



    Prof. M. Brown (UCL)


    		 Assigned Registrar:

    Associated Staff:

    brains

    Last updated 29 Jan 2008
    Email: NCTU@ncl.ac.uk
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