The ROADSTER Study* presents pivotal results in a prospective, single-arm, multi-center trial of the TCAR Procedure using the ENROUTE® Transcarotid Neuroprotection System (NPS) in high surgical risk patients with carotid artery stenosis.
*J Vasc Surg 2015;62:1227-35
The TCAR Procedure is designed to protect the brain from stroke throughout the carotid revascularization procedure. The ENROUTE Transcarotid NPS temporarily reverses blood flow during the TCAR procedure to divert micro and macro emboli away from the brain. Even small emboli, not large enough to cause a major stroke, can cause a minor brain infarction and impact cognitive function in the near and long term.
Below are the results of the TCAR Procedure in patients at high risk for surgery compared to standard risk patients undergoing carotid endarterectomy (CEA) for the treatment of carotid artery disease.
TCAR 30-Day All Stroke
HIGH SURGICAL RISK PATIENTS
ROADSTER* STUDY n=141
CEA 30-Day All Stroke
STANDARD SURGICAL RISK PATIENTS
CREST STUDY n=1240
Less Invasive and Patient-Friendly
The TCAR procedure requires a smaller skin incision than traditional CEA procedure and can be performed more often using local anesthesia. With a smaller incision, cranial nerve injury (CNI) rates are reduced and scarring is minimized.
Cranial Nerve Injury Rates
TCAR – ROADSTER Study
CNI unresolved at 6 months
CEA – CREST Study
CNI unresolved at 6 monthsCirculation 2012:125:2256-2264
The TCAR procedure is completed through a small needle puncture, rather than a surgical incision in the carotid artery. This transcarotid approach reduces the amount of time needed for the patient to be on reverse flow compared to the arterial clamp time of a carotid endarterectomy (CEA) procedure.
REVERSE FLOW TIME
TCAR – ROADSTER Study n=141
CEA – NASCET Study n=1,4154
ROADSTER Study Clinical Results
ROADSTER Study Demographics and Technical Results