Silk Road Medical, a company focused on stroke, announced positive final results for its ROADSTER-2 post-marketing study to evaluate the use of the ENROUTE Neuroprotection and Stent Systems in TransCarotid Artery Revascularization (TCAR) procedures.
The results of the study have been presented by chief of vascular surgery and endovascular therapy at University Hospitals Case Medical Center (Cleveland, OH) and National Co-Principal Investigator of ROADSTER-2, Dr. Vikram Kashyap at the Society for Vascular Surgery 2019 Vascular Annual Meeting (VAM).
The study showed positive patient outcomes with low stroke and combined stroke and death rates of 0.6% and 0.8%, respectively, in 632 high surgical risk patients enrolled across 42 sites. 70% of patients enrolled in the study were from physicians new to TCAR.
Kashyap said: “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.
“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.”
Silk Road Medical said that it has designed the ROADSTER-2 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.
According to the company, 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%.
The study showed TCAR to have low rates of 30-day major adverse events, including1.7% 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.
Silk Road Medical chief executive officer Erica Rogers said: “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 TCAR Surveillance Project, supports the case for TCAR as the standard of care in high surgical risk patients.”