The first patient has been enrolled in the US ROADSTER 2 post approval study at Greenville Memorial Hospital in Greenville, USA.
ROADSTER 2—a prospective, multicentre study—is designed to analyse the real-world effects of the recently FDA-approved Enroute transcarotid neuroprotection and stent system for the treatment of patients at risk of stroke due to carotid artery disease. According to Silk Road Medical, these are the first devices designed specifically for transcarotid artery revascularisation (TCAR).
The study will include a minimum of 600 patients at up to 100 sites and is being led by co-national principal investigators Peter Schneider, chief of vascular at Kaiser Foundation Hospital in Honolulu, Hawaii, and Vikram Kashyap, chief of vascular and endovascular surgery, University Hospitals Case Medical Center, Cleveland, USA.
Bruce Gray, who performed the procedure with his colleagues Mark Androes and Joseph Blas, says, “With traditional surgical repair where we cut open the neck and carotid artery, there is always an underlying risk of serious complications including heart attack and nerve injury. The TCAR procedure combines surgical principles of protecting the brain with advanced endovascular stent technology to treat patients in a far less invasive and safe manner.”
The ROADSTER 2 study is a follow up to the ROADSTER study, which evaluated the TCAR procedure in 141 patients at high risk for complications from surgery with a composite primary endpoint result of 3.5% stroke, death, or myocardial infarction through 30 days.
“In the ROADSTER study we achieved the lowest reported 30-day stroke rate of any prospective study of carotid revascularisation at 1.4% in the Intent to Treat patient population and 0.7% in the Per Protocol population,” says Kashyap.
“Importantly, there were no strokes in high risk subgroups, including symptomatic patients, elderly patients over the age of 75, and female patients. We look forward to building upon this excellent clinical evidence base in the ROADSTER 2 study.”
“We have been seeking a less invasive alternative to traditional carotid surgery,” said Schneider. “With TCAR and the Enroute transcarotid platform we have incorporated decades of learning from surgical and endovascular techniques into a hybrid procedure that has shown impressive clinical results to date.”