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The PROOF Study

“DW-MRI findings suggest controlled reverse flow provides cerebral embolic protection similar to that seen with CEA.”

– J Vasc Surg. 2011 Nov;54(5):1317-23

The PROOF Study* presents first in man results of the TCAR Procedure using the ENROUTE® Transcarotid Neuroprotection System in 75 patients. 

Establishing the Safety of TCAR

The PROOF Study demonstrated a 0% rate of major stroke, death and myocardial infarction through 30 days in 71 patients available for follow-up. 

Low Rate of new White Lesions
Micro-Emboli Measurement

The PROOF Study presented very low rates of new white lesions detected through DW-MRI. The 17.9% rate of ipsilateral 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.

DW-MRI Studies
Equivalent DW-MRI results for TCAR & CEA.

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. 

The learning curve is short and steep, as people get good within five cases or so, and are able to get outstanding outcomes.

Marc Schermerhorn, MD – Beth Israel Deaconess Hospital, Boston, MA,
TCAR Surveillance Project Study Chair

Related publications

Transcarotid Artery Revascularization Results in Low Rates of Periprocedural Neurologic Events, Myocardial Infarction, and Death.

Curr Cardiol Rep 22(1): 3. 

Transcervical Carotid Stenting With Dynamic Flow Reversal Demonstrates Embolization Rates Comparable to Carotid Endarterectomy.

J Endovasc Ther 23(2): 249-254. 

A diffusion-weighted magnetic resonance imaging-based study of transcervical carotid stenting with flow reversal versus transfemoral filter protection.

J Vasc Surg 56(6): 1585-1590. 

Discover more clinical studies

Pre-Market Approval of the ENROUTE Neuroprotection System.

Post Approval registry validating safety and efficacy of the ENROUTE Stent.

Real world population data validating CEA-like outcomes.

Validation of superior outcomes
to TF-CAS.