A randomised comparison of the risks, benefits and cost effectiveness of primary carotid stenting with cartotid endarterectomy: International Carotid Stenting Study
- Conditions
- Carotid stenosis/strokeCirculatory SystemCerebral infarction
- Registration Number
- ISRCTN25337470
- Lead Sponsor
- niversity College London (UK)
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
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
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
7. Patients in whom it is planned to carry out coronary artery bypass grafting or other major surgery within 1 month of carotid stenting or endarterectomy
8. Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy
9. Previous carotid endarterectomy or stenting in the randomised artery
10. Patients in who common carotid artery surgery is planned
11. Patients medically not fit for surgery
12. Patients who have a life expectancy of less than two years due to a pre-existing condition, e.g. cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Added as of 07/02/2007: <br>1. Any stroke or death<br>2. MI Within 30 days of treatment
- Secondary Outcome Measures
Name Time Method Added as of 07/02/2007: <br>1. Cranial nerve palsy within 30 days of treatment<br>2. Haematoma caused by treatment requiring surgery<br>3. Transfusion or prolonging hospital stay<br>4. Stenosis greater than 70% or occlusion during follow up<br>5. Further treatment of the randomised artery by interventional radiology techniques or surgery after the initial attempt<br>6. Quality of life<br>7. Health status <br>8. Health Service costs