ROADSTER Study

The ROADSTER Study* presents pivotal and continued access 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 2016;63(6 Suppl):4S

CEA-Like Neuroprotection

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

    0

    1.4

    HIGH SURGICAL RISK PATIENTS
    ROADSTER STUDY n=219
  •  

    CEA 30-Day All Stroke

    0

    2.3

    STANDARD SURGICAL RISK PATIENTS
    CREST STUDY n=1,240
    N Engl J Med 2010; 363:11-23

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

     

    0

    0.5%

     

    0.0%

    CNI unresolved at 6 months

  • CEA – CREST Study

     

    0

    5.3%

    80% Affecting Motor Skills

     

    0

    2.1%

    CNI unresolved at 6 months

    Circulation 2012:125:2256-2264

Actual patient scars – TCAR incision

(Click for larger image)

Transcarotid Efficiency

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.

  • Tcar

    0
    10

    minutes

    REVERSE FLOW TIME

    MEDIAN

    TCAR – ROADSTER Study n=219

  • CEA

    0
    31

    minutes

    CLAMP TIME

    MEDIAN

    CEA – NASCET Study n=1,415
    Stroke 1999;30:1751-1758

ROADSTER Study Clinical Results

ROADSTER Study Demographics and Technical Results

Acute Device Success
ENROUTE NPS delivered, reverse flow established, device removed from vasculature
Technical Success
Acute Device Success with successful introduction of interventional tools.
Procedural Success
Technical Success without the occurrence of MAE 30-days post procedure