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Stent-protected angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy: SPACE2--a three-arm randomised-controlled clinical trial
International Journal of Stroke, 08/17/09
Reiff T et al. – A clinical trial protocol is presented for SPACE2, a 3-arm randomized-controlled clinical trial, for stent-protected angioplasty in asymptomatic carotid artery stenosis vs endarterectomy.
Methods- Presentation of clinical trial protocol for SPACE2
- Trial design: hierarchical
- Recruitment target: 3640 pts
- Superior trial of intervention (carotid artery stenting or carotid endarterectomy) vs state-of-the-art conservative treatment
- In case of superior interventions, test of noninferiority endpoint between carotid artery stenting and carotid endarterectomy
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