Methods
141 high surgical risk patients (Symptomatic ≥ 50% stenosis; Asymptomatic ≥ 70% stenosis) were enrolled in 18 sites. In the pivotal cohort, 26% were symptomatic. Primary endpoint was the composite of all stroke MI and death at 30 days post-procedure. Secondary end points included mCNI, 30-day stroke/death and procedural success.
Findings
The all-stroke rate in the ITT group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). There were no major strokes. One patient (0.7%) experienced postoperative hoarseness from potential cranial nerve injury, which completely resolved at the 6-month follow-up visit. Technical success was 99% (140 of 141) with mean procedure time of 74 minutes. Local anesthesia was used in 53% of cases.
Conclusions
The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at reducing stroke during TCAR. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.
