In-stent restenosis associated with dual-layer Roadsaver carotid artery stent: a retrospective single-center study.

Aim: To evaluate the incidence of in-stent restenosis (ISR) at 12-month follow-up, in patients treated with new dual-layer Roadsaver (Terumo Corp, Tokyo, Japan) carotid artery stent (CAS).

Materials And Methods: Thirteen patients underwent CAS and received a Roadsaver. Neurological examination was performed in all patients. Carotid stenosis was revealed by Doppler ultrasound (DUS) and multidetector CT (MDCT) scan. Four patients presented a peak systolic velocity (PSV) between 130 and 150 cm/s, six a PSV between 150 and 180 cm/s, and three a PSV > 180 cm/s. MDCT gave further anatomic information. Direct stenting was performed in 11 (84.6%) cases, whereas in 2 (15.4%) cases predilatation was required. In all cases postdilatation was performed. Technical and clinical success and safety were evaluated. Stent patency was evaluated during the 12-month follow-up.

Results: Technical success was achieved in all cases. In three patients a nonsignificant residual stenosis < 30% has been reported. No major complications during or after the procedure occurred. One patient (7.7%) showed a transitory bradycardia during angioplasty. One (7.7%) local bleeding at the puncture site treated conservatively occurred. All the neurological examinations performed 24 h and 30 days after the procedure were negative. No significant ISR was registered. In 2 patients, < 30% ISR was revealed at DUS performed after 6 months and confirmed at 12 months. In both patients CEUS and MDCT denied the presence of significant stenosis.

Conclusions: Roadsaver stent seems to be durable. Further studies with longer-term outcome are necessary to confirm our results.