Silk Road Medical Announce ROADSTER 3 Clinical Trial Results

Silk Road Medical released positive 30-day results from its ROADSTER 3 clinical trial testing the effectiveness and safety of Transcarotid Artery Revascularization (TCAR) for treating carotid stenosis in patients at standard surgical risk (SSR).

ROADSTER 3 was the first-ever prospective, multicenter evaluation of the ENROUTE Transcarotid Stent System (TSS) in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) for treating carotid stenosis in this patient population, achieved the lowest reported outcomes in SSR.

Between 2022 and 2024, 344 intent-to-treat (ITT) patients were enrolled (320 treated per protocol) at 53 US sites. The primary endpoint for this single-arm, post-approval study was a composite of major adverse events (stroke, death, or myocardial infarction) through 30 days post-procedure, plus ipsilateral stroke from day 31 to 365 post-procedure.

The incidence of cranial nerve injury (CNI) within 30 days post-procedure is a key secondary endpoint. Independent neurological assessments are performed for all patients before the procedure, within 24 hours, at 30 days, and 1 year after TCAR. An independent clinical events committee adjudicated the events.

TCAR has been performed on over 100,000 patients in the U.S. since 2015. These findings build on the initial results from ROADSTER & ROADSTER 2, which established the safety and effectiveness of TCAR as a primary strategy for patients with extracranial carotid artery disease. 

Following the FDA and in continued efforts to demonstrate the impact of TCAR, ROADSTER 3 was launched to evaluate TCAR in the standard surgical risk population.

The results from ROADSTER 3 showed that TCAR, using the ENROUTE TSS in conjunction with the ENROUTE NPS, is safe and effective in patients at standard risk for adverse events from carotid endarterectomy.

In the ITT population, 75.3% were less than 75 years of age, 42.7% were female, and 16.3% were symptomatic. Among symptomatic patients, 25.0% experienced a neurologic event within 2 weeks preceding the TCAR procedure. The average lesion length was 23.3mm. 47.4% had a Type II or Type III aortic arch, and 17.2% of lesions had severe calcification. 

In the ITT population, the rate of stroke/death/MI at 30 days was 0.9% (0.6% PP), with a 30-day stroke rate of 0.9% (0.6% PP, n=2). There were no deaths or MIs through 30-day follow-up. The incidence of CNI within 30 days was 0.6% (0.6% PP); both resolved within 6 months.

The results of the clinical trial were announced at VIVA and The VEINS 2024 this week in Las Vegas.