A novel dual-layer stent system was safe and effective at 12 months, according to data from the CLEAR-ROAD study.
The researchers conducted a single-arm, prospective study of the dual-layer stent system (Roadsaver, Terumo) in 100 patients with carotid artery stenosis at high surgical risk.
“The introduction of dual-layer stents might reduce the periprocedural risk of embolization by extensive plaque coverage and prevention of plaque prolapse,” Marc Bosiers, MD, from the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium, and colleagues wrote.
All patients received carotid duplex ultrasound and a NIH Stroke Scale score at 30 days, 6 and 12 months. Use of embolic protection devices was at the discretion of the operator, and patients were recommended to take clopidogrel 75 mg per day for 1 month after the procedure and aspirin 75 mg to 300 mg per day for the rest of their lives.
There were three ipsilateral strokes between 1 and 12 months, for a rate of freedom from ipsilateral stroke of 95.8%, Bosiers and colleagues wrote.
At 12 months, primary patency was 92.5% and freedom from target lesion revascularization was 97.9%.
NIH Stroke Scale score improved over time for most patients, according to the researchers.
The 12-month stroke rate was less than that seen for carotid stenting in the ICSS and CREST studies, so “the treatment of a carotid stenosis with the Roadsaver stent is effective in preventing long-term (1-year) ipsilateral stroke,” Bosiers and colleagues wrote. – by Erik Swain
Disclosures: The study was funded by Terumo. Bosiers reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.