What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are balloon guide catheter, or No Proximal Protection Group. The registry lists allocation as randomized. Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization.
They plan to enroll about 126 people at Santander. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)
Interventions: balloon guide catheter, No Proximal Protection Group
Primary outcome (registry wording): Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting