A randomised comparison of the risks, benefits and cost effectiveness of primary carotid stenting with cartotid endarterectomy: International Carotid Stenting Study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London (UK)
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17395869 initial RCT results 2007 Results article in http://www.ncbi.nlm.nih.gov/pubmed/17848682 computed tomographic measurement results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20189239 results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20189458 sub-study results 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21880992 cognition effect results 2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21998053 hypertension results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23238861 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23237679 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23578600 blood flow velocity results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23849948 white-matter lesions results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23954165 flow velocities in the external carotid artery results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24203845 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24368558 predictors for acute and persisting periprocedural ischemic brain lesions results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23834300 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25344019 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25453443 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25677309 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26460291 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26481656 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26979174 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28400487 results 2018 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/29861139 secondary analysis 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30355202 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31378071 results (added 06/08/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31547798 results (added 27/09/2019) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37615093/ Secondary observational prospective cohort analysis (added 25/08/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Symptomatic, extracranial, internal or bifurcation, atheromatous carotid artery stenosis that is suitable for both stenting and surgery and is deemed by the randomising clinician to require treatment
- •2\. The severity of the stenosis of the randomised artery should be at least 50% (as measured by the North American Symptomatic Carotid Endarterectomy Trial \[NASCET] method or non\-invasive equivalent)
- •3\. Symptoms must have occurred in the 12 months before randomisation. It is recommended that the time between symptoms and randomisation should be less than 6 months, but patients with symptoms occurring between 6 and 12 months may be included if the randomising physician considers treatment indicated
- •4\. The patient must be clinically stable following their most recent symptoms attributable to the stenotic vessel
- •5\. Patients must be willing to have either treatment, be able to provide informed consent, and be willing to participate in follow up
- •6\. Patients must be able to undergo their allocated treatment as soon as possible after randomisation
- •7\. Any age greater than 40 may be included. There is no upper age limit.
- •8\. Patients should only be randomised if the investigator is uncertain which of the two treatments is best for that patient at that time
Exclusion Criteria
- •1\. Patients refusing either treatment
- •2\. Patients unable or unwilling to give informed consent
- •3\. Patients unwilling or unable to participate in follow up for whatever reason
- •4\. Patients who have had a major stroke with no useful recovery of function within the territory of the treatable artery
- •5\. Patients with a stenosis that is known to be unsuitable for stenting prior to randomisation because of one or more of:
- •5\.1\. Tortuous anatomy proximal or distal to the stenosis
- •5\.2\. Presence of visible thrombus
- •5\.3\. Proximal common carotid artery stenotic disease
- •5\.4\. Pseudoocclusion ('string sign')
- •6\. Patients not suitable for surgery due to anatomical factors e.g. high stenosis, rigid neck
Outcomes
Primary Outcomes
Not specified