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The ROADSTER trials
TCAR by ENROUTE is a safe and effective procedure for treating carotid artery disease. The ROADSTER clinical trials have demonstrated low rates of stroke, death, and myocardial infarction (MI) within 30 days post-procedure1. The ROADSTER 3 study, which included standard-risk patients, reported a 30-day stroke rate of 0.9%, with no deaths or MIs1. Additionally, ENROUTE has been shown to have lower rates of cranial nerve injury compared to Carotid Endarterectomy (CEA)2. These findings support ENROUTE as a viable, less invasive alternative to traditional surgical methods, offering robust neuroprotection and positive patient outcomes.
Demonstrating consistent, low adverse event rates across all risk levels
ITT = intent to treat
PP = per protocol
References:
1. Dermody, M. (2024). Prospective, Multicenter Evaluation of Transcarotid Artery Revascularization (TCAR) in Standard Risk Patients: 30-Day Outcomes of the ROADSTER 3 Study. Presented at VIVA Conference 2024.
2. Stonko DP, Goldsborough E, Kibrik P, Zhang G, Holscher CM, Hicks CW. Use of Transcarotid Artery Revascularization, Transfemoral Carotid Artery Stenting, and Carotid Endarterectomy in the US From 2015 to 2019. JAMA Netw Open. 2022;5(9):e2231944. doi:10.1001/jamanetworkopen.2022.31944
3. Kwolek CJ, et al. Results of the ROADSTER multicenter trial of transcarotid stenting with dynamic flow reversal. J Vasc Surg. 2015 Nov;62(5):1227-34
4. Kashyap VS, et al. ROADSTER 2 Investigators*. Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease. Stroke. 2020 Sep;51(9):2620-2629