A Novel, Self-Expanding, Nitinol Stent in Medically Refractory Intracranial Atherosclerotic Stenoses

TLDR

High‑grade intracranial atherosclerotic stenosis that fails medical therapy is a leading cause of stroke, and endovascular devices such as the Wingspan stent and Gateway balloon are being explored for treatment. This study aimed to evaluate the safety and performance of the Wingspan stent system and Gateway balloon catheter in patients with medically refractory intracranial stenosis. In a prospective, multicenter, single‑arm trial, 45 patients with ≥50 % stenosis in vessels 2.5–4.5 mm and modified Rankin ≤3 were enrolled; lesions were predilated with an undersized Gateway balloon to 80 % of vessel diameter, then a self‑expanding Wingspan stent was deployed, and neurologic exams and angiograms were performed at 6 months. Stenting reduced stenosis from 74.9 % to 31.9 % immediately and to 28 % at 6 months; the 30‑day ipsilateral stroke/death rate was 4.5 %, rising to 7.0 % at 6 months, with overall stroke 9.7 % and mortality 2.3 %, and physician‑reported follow‑up noted one additional ipsilateral stroke, indicating the approach is safe and yields favorable angiographic outcomes.

Abstract

Background and Purpose— The purpose of this study was to assess the safety and performance of the Wingspan stent system and Gateway percutaneous transluminal angioplasty balloon catheter in the treatment of high-grade, intracranial atherosclerotic lesions in patients who had failed medical therapy. Methods— In this prospective, multicenter, single-arm study, medically refractory patients with a modified Rankin score ≤3 and recurrent symptoms attributable to angiographically demonstrated intracranial stenosis ≥50% in a vessel 2.5 to 4.5 mm in diameter were enrolled. Intracranial lesions were predilated with an undersized Gateway balloon catheter to 80% of the native vessel diameter, followed by deployment of the self-expanding Wingspan stent to facilitate further remodeling of the atherosclerotic plaque and to maintain vessel patency. Neurologic examinations and angiograms were performed at 6 months after the procedure. Results— Among the 45 patients enrolled, the degree of stenosis was reduced from a baseline of 74.9±9.8% to 31.9±13.6% after stenting and 28±23.2% at the 6-month follow-up. The 30-day composite ipsilateral stroke/death rate was 4.5% (2/44); at the 6-month follow-up, the ipsilateral stroke/death rate was 7.0%, the rate for all strokes was 9.7%, and all-cause mortality was 2.3%. Physician-reported follow-up in 43 patients (average of 13 months) conducted outside the study protocol (not adjudicated by the clinical event committee) reported 1 additional ipsilateral stroke. Conclusions— In medically refractory patients with high-grade intracranial atherosclerotic stenoses, a new treatment paradigm involving predilation with an undersized Gateway percutaneous transluminal angioplasty balloon catheter and placement of a self-expanding Wingspan stent system appears to be safe, may facilitate remodeling, and may contribute to favorable angiographic outcomes.