A randomised comparison of the risks, benefits and cost effectiveness of primary carotid stenting with cartotid endarterectomy: International Carotid Stenting Study
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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