Bose A.Hartmann M.Henkes H.HON-MAN LIUTeng M.M.H.Szikora I.Berlis A.Reul J.Yu S.C.H.Forsting M.Lui M.Lim W.Sit S.P.2020-08-212020-08-2120070039-2499https://scholars.lib.ntu.edu.tw/handle/123456789/513430BACKGROUND 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. ? 2007 American Heart Association, Inc.[SDGs]SDG3acetylsalicylic acid; clopidogrel; nitinol; adverse outcome; aged; article; atherosclerotic plaque; balloon catheter; blood vessel; blood vessel diameter; brain atherosclerosis; brain damage; brain hematoma; clinical article; clinical trial; controlled clinical trial; controlled study; epiglottis edema; female; fever; follow up; heart arrhythmia; human; hyperglycemia; hypertension; hypervolemia; male; mortality; multicenter study; neurologic examination; nystagmus; percutaneous transluminal angioplasty; physician; postoperative complication; priority journal; prospective study; Rankin scale; respiratory failure; risk assessment; scoring system; stent; stroke; symptom; vascular patency; Aged; Alloys; Angioplasty, Balloon; Female; Humans; Intracranial Arteriosclerosis; Male; Prospective Studies; Stents; Treatment Outcomejournal article10.1161/STROKEAHA.106.477711173958642-s2.0-34247573435