THE PROOF STUDY
The PROOF Study presents the first in man results of the TCAR Procedure using the ENROUTE Transcarotid Neuroprotection System in 75 patients.
No Major Adverse Events
The PROOF Study demonstrated a 0% rate of major stroke, death and myocardial infarction through 30 days in 71 patients available for follow-up. The one minor stroke in the Study presented on the contralateral (opposite) side of the brain and was determined not to be related to the ENROUTE System or TCAR Procedure. A very low rate of cranial nerve injury presented in 2 patients in the form of hoarseness.
1. J Vasc Surg 2011;54:1317-23
2. Kolvenbach, Ralf, MD PhD. ” Transcervical Carotid Revascularization with Flow Reversal Neuroprotection: Final Results from the Silk Road Medical Neuroprotection System: First-In-Man PROOF Study.” VEITH Meeting, Nov 2012
Low Rate of new DW-MRI Lesions
DW-MRI: Diffusion Weighted Magnetic Resonance Imaging of the brain is a diagnostic tool that can be applied during routine MRI scanning. DW-MRI is an extremely sensitive test that can detect major and very minor degrees of ischemic damage to the brain where brain tissue is being starved of oxygen rich blood. Often, these ischemic lesions may be clinically silent (silent stroke) and do not present in the form of a visible stroke, but in some instances, these ischemic areas manifest in permanent brain damage. Recent studies suggest that silent strokes might be a contributing factor to the onset of dementia and other neurological deficits later in life.
Low rates of these new DW-MRI lesions are clearly the clinical goal and the 17.9% rate of the TCAR procedure from the PROOF Study are quite comparable to the more invasive, clinically proven method of an open surgical repair of carotid endarterectomy.
DW-MRI Studies – Silk Road’s CEA-Like Outcomes