ROADSTER 3 Data Reported for Boston Scientific’s Enroute TCAR Devices

November 4, 2024—The prospective, multicenter ROADSTER 3 postapproval trial is evaluating the safety and effectiveness of transcarotid artery revascularization (TCAR) using the Enroute transcarotid stent system (TSS; Boston Scientific Corporation) in conjunction with the Enroute transcarotid neuroprotection system (NPS; Boston Scientific Corporation) for the treatment of carotid stenosis in standard surgical-risk patients.

Meghan Dermody, MD, presented the ROADSTER 3 findings in the second late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, the primary endpoint for this single-arm study is a composite of major adverse events (stroke, death, or myocardial infarction [MI]) through 30 days postprocedure, plus ipsilateral stroke from day 31 to 365 postprocedure. A key secondary endpoint is the incidence of cranial nerve injury (CNI) within 30 days postprocedure.

All patients underwent independent neurologic assessments before the procedure, and within 24 hours, at 30 days, and at 1 year after TCAR. Events were adjudicated by an independent clinical events committee.

The VIVA24 press release stated that the trial enrolled 344 patients (320 treated per-protocol [PP]) at 53 United States sites. Patient characteristics included: age < 75 years, 75.3%; female, 42.7%; symptomatic, 16.3%.

Among symptomatic patients, 25% experienced a neurologic event within 2 weeks preceding TCAR. The mean lesion length was 23.3 mm; 47.4% had a type II or type III aortic arch; and 17.2% of lesions had severe calcification.

As reported in the VIVA24 press release, in the intent-to-treat population, the rate of stroke/death/MI at 30 days was 0.9% (PP, 0.6%) with a 30-day stroke rate of 0.9% (PP, 0.6%). There were no deaths or MIs through 30-day follow-up. The incidence of CNI within 30 days was 0.6% (PP, 0.6%); both resolved within 6 months.

These 30-day results of the ROADSTER 3 study demonstrated 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, concluded the VIVA24 press release.

The ROADSTER 3 trial was initiated in September 2022 by Silk Road Medical, Inc, the developer of the Enroute devices. Silk Road was acquired by Boston Scientific in September 2024.