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11 February 2012
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| [ Print-friendly version ] |
| A randomised comparison of the risks, benefits and cost effectiveness of primary carotid stenting with cartotid endarterectomy: International Carotid Stenting Study |
| ISRCTN | ISRCTN25337470 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised comparison of the risks, benefits and cost effectiveness of primary carotid stenting with cartotid endarterectomy: International Carotid Stenting Study |
| Scientific title | |
| Acronym | ICSS |
| Serial number at source | N/A |
| Study hypothesis |
Added as of 07/02/2007:
To compare the risks, benefits and cost effectiveness of a treatment policy of referral for carotid stenting compared with referral for carotid surgery, in patients with symtomatic carotid stenosis. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Not provided at time of registration
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| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom, International |
| Disease/condition/study domain | Carotid stenosis/stroke |
| Participants - 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 |
| Participants - 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 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 |
| Anticipated start date | 01/05/2000 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Completed |
| Patient information material | Patient information sheet available at: http://www.ion.ucl.ac.uk/cavatas_icss/downloads/Infosheet.pdf |
| Target number of participants | 36 |
| Interventions | Patients will be randomised in equal proportions to be treated by carotid endarterectomy or stenting. |
| Primary outcome measure(s) |
Added as of 07/02/2007:
1. Any stroke or death 2. MI Within 30 days of treatment |
| Secondary outcome measure(s) |
Added as of 07/02/2007:
1. Cranial nerve palsy within 30 days of treatment 2. Haematoma caused by treatment requiring surgery 3. Transfusion or prolonging hospital stay 4. Stenosis greater than 70% or occlusion during follow up 5. Further treatment of the randomised artery by interventional radiology techniques or surgery after the initatil attempt 6. Quality of life 7. Health status 8. Health Service costs |
| Sources of funding | Medical Research Council (MRC) (UK) |
| Trial website | http://www.cavatas.com |
| Publications |
1. 2007 initial RCT results in http://www.ncbi.nlm.nih.gov/pubmed/17395869
2. 2007 computed tomographic measurement results in http://www.ncbi.nlm.nih.gov/pubmed/17848682 3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20189239 4. 2010 sub-study results in http://www.ncbi.nlm.nih.gov/pubmed/20189458 5. 2011 cognition effect results in http://www.ncbi.nlm.nih.gov/pubmed/21880992 |
| Contact name | Prof Martin M Brown |
| Address |
Professor of Stroke Medicine
Institute of Neurology University College London Box 6, National Hospital for Neurology & Neurosurgery Queen Square |
| City/town | London |
| Zip/Postcode | WC1N 3BG |
| Country | United Kingdom |
| Tel | +44 (0)20 7829 8753 |
| Fax | +44 (0)20 7833 8613 |
| m.brown@ion.ucl.ac.uk | |
| Sponsor | University College London (UK) |
| Address | Gower Street |
| City/town | London |
| Zip/Postcode | WC1E 6BT |
| Country | United Kingdom |
| Date applied | 15/04/2005 |
| Last edited | 08/11/2011 |
| Date ISRCTN assigned | 12/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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