The ROADSTER 2 Clinical Study
This study evaluated usage of the ENROUTE® Transcarotid Stent System in conjunction with the ENROUTE® Transcarotid Neuroprotection System in high surgical risk patients with carotid artery stenosis. 692 patients were treated across 43 sites, with 81% of the physician enrollers being new TCAR operators.
“The stroke rate of 0.6% after TCAR in the Per Protocol population may be the lowest reported rate after any carotid intervention.”
–Stroke 2020; 51:2620–2629
Results of the ROADSTER 2 Study
![CNI8](https://silkroadmed.com/wp-content/uploads/2020/10/CNI8.jpg)
![CNI9-V2](https://silkroadmed.com/wp-content/uploads/2022/07/CNI9-V2.jpg)
*All CNI injuries resolved in patients that consented to an extended follow up period.
![](https://silkroadmed.com/wp-content/uploads/2020/09/SRM_ClinicalResults_Icon_2.png)
0.6% stroke rate in the FDA Analysis Population (PP)
![](https://silkroadmed.com/wp-content/uploads/2020/09/SRM_ClinicalResults_Icon_3.png)
81% of Physicians were new to TCAR
![](https://silkroadmed.com/wp-content/uploads/2020/09/SRM_ClinicalResults_Icon_1.png)
Excellent outcomes achievable with adherance to Protocol
![Vikram_Kashyap_Circle](https://silkroadmed.com/wp-content/uploads/2020/10/Vikram_Kashyap_Circle.png)
TCAR continues to show a low stroke and death rate with lower rates of cranial nerve injury compared to CEA, which we believe will further instill physician confidence and adoption.”
Vikram Kashyap, MD – University Hospitals Case Medical Center, Cleveland, OH,
Chief of Vascular Surgery and Endovascular Therapy
Related publications
![](https://silkroadmed.com/wp-content/uploads/2020/10/SRM_ClinicalResults_Publications_J_of_VascularSurgery_620x397pxl.jpg)
Results of the ROADSTER Multicenter Trial of Transcarotid Stenting with Dynamic Flow Reversal
Kwolek CJ et al.
![](https://silkroadmed.com/wp-content/uploads/2020/10/SRM_ClinicalResults_Publications_J_of_VascularSurgery_620x397pxl.jpg)
One-Year Results of the ROADSTER Multicenter Trial of Transcarotid Stenting With Dynamic Flow Reversal
Mahmoud Malas et al.
![](https://silkroadmed.com/wp-content/uploads/2020/10/SRM_ClinicalResults_Publications_J_of_VascularSurgery_620x397pxl.jpg)
Pre- and Post-TCAR Characteristics of Common Carotid Artery: A Post Hoc Analysis of ROADSTER-1 Trial
Raghu L. Motaganahalli et al
![](https://silkroadmed.com/wp-content/uploads/2020/10/SRM_ClinicalResults_Publications_J_of_VascularSurgery_620x397pxl.jpg)
The ROADSTER Investigational Device Exemption Trial Leads to FDA Approval of the First Stent Labeled for TCAR
Manish Mehta et al.
Discover more clinical studies
![](https://silkroadmed.com/wp-content/uploads/2020/10/SRM_ClinicalResult_LandingPage_TCAR_PROOF.jpg)
First in man results using ENROUTE® Transcarotid Neuroprotection System.
![](https://silkroadmed.com/wp-content/uploads/2020/10/Frame-2-ROADSTER-Study.jpg)
Pre-Market Approval of the ENROUTE Neuroprotection System.
![](https://silkroadmed.com/wp-content/uploads/2020/10/Frame-3-TCAR-Surveillance-Study.jpg)
Real world population data validating CEA-like outcomes.
![](https://silkroadmed.com/wp-content/uploads/2020/10/Frame-4-TCAR-vs-TF-CAS.jpg)
Validation of superior outcomes
to TF-CAS.