Final Results Presented in Late-Breaking Session
NATIONAL HARBOR, Md.,
In the late-breaking session at the
“The results of ROADSTER-2 continue to demonstrate the safety, effectiveness and clinical advantages of TCAR, especially given that a majority of the TCAR procedures were performed by a broad group of physicians with no previous TCAR experience,” Dr. Kashyap said. “The study results highlight the short learning curve of the TCAR procedure and its remarkable consistency and reproducibility, and, I believe, will further encourage physicians to broadly adopt the TCAR procedure.”
Designed as a follow-on study to the pivotal ROADSTER trial, ROADSTER-2 is a prospective, multi-center study designed to assess the real-world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the TCAR procedure. The study met its primary endpoint of procedural success, defined as acute device and technical success in the absence of stroke, death or myocardial infarction (MI) at 30 days, at 97.9%.
Significant findings from the study showed TCAR to have low rates of 30-day major adverse events, including:
- 1.7% stroke, death and MI
- 0.8% stroke and death
- 0.6% stroke, including 0.6% in symptomatic patients, 0.5% in females, and 1.1% in patients age greater than 75
In addition, ROADSTER-2 showed lower rates of acute (1.3%) and permanent (0.5%) cranial nerve injury than is typically observed for patients receiving carotid endarterectomy (CEA), the current standard of care.
“The mounting clinical evidence base demonstrates the compelling patient benefits of TCAR, which we believe will further support physician confidence and adoption. The data from ROADSTER-2, taken together with recent updated results from the
About TCAR with the ENROUTE Transcarotid Neuroprotection and Stent System
TCAR (TransCarotid Artery Revascularization) is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The ENROUTE Transcarotid Stent is intended to be used in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The ENROUTE Transcarotid NPS is a first in class device used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the ENROUTE Transcarotid Stent.
ENROUTE is a registered trademark of
Source: Silk Road Medical