PROOF Study

The PROOF Study* presents first in man results of the TCAR Procedure using the ENROUTE® Transcarotid Neuroprotection System in 75 patients. Zero primary endpoint events and surgical-like rate of new white lesions in the DW-MRI sub study.

*J Vasc Surg 2011;54:1317-23

No Primary Endpoint 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 Neuroprotection System or the TCAR Procedure. Due to the small size and lower position of the surgical incision, a very low rate of cranial nerve injury was observed 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 White Lesionsproof_lesions

Micro-Emboli Measurement

The PROOF Study presented very low rates of new white lesions detected through DW-MRI. The 17.9% rate of new white lesions for the TCAR procedure in the PROOF Study are quite comparable to the more invasive, traditional method of the open surgical repair of carotid endarterectomy.3 (CEA).

DW-MRI Studies – Silk Road’s CEA-Like Outcomes

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.

  1. J Am Coll Cardiol. 2012 Jan 19.
  2. Lancet Neurol. 2010 Apr;9(4):353-62
  3. 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
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