Long-term histopathologic and IVUS evaluations of a novel coiled sheet stent in porcine carotid arteries

• Published in: Cardiovascular and interventional radiology 2006-06, Vol.29 (3), p.413-419
• Main Authors: Kaneda, Hideaki, Ikeno, Fumiaki, Lyons, Jennifer, Rezaee, Mehrdad, Yeung, Alan C, Fitzgerald, Peter J
• Format: Article
• Language: English
• Subjects: Alloys; Analysis of Variance; Angioplasty; Angioplasty, Balloon; Animals; CAROTID ARTERIES; Carotid Stenosis - diagnostic imaging; Carotid Stenosis - therapy; EVALUATION; Fluoroscopy; INJURIES; LASERS; NICKEL ALLOYS; Prosthesis Design; RADIOLOGY AND NUCLEAR MEDICINE; Stents; SWINE; TITANIUM ALLOYS; Ultrasonography, Interventional; VASCULAR DISEASES; Veins & arteries
• ISSN: 0174-1551; 1432-086X
• DOI: 10.1007/s00270-005-0137-6

Carotid angioplasty with stent placement has been proposed as an alternative method for revascularization of carotid artery stenosis. A novel stent with a laser-cut, rolled sheet of Nitinol (EndoTex Interventional Systems, Inc., Cupertino, CA) has been developed to customize treatment of stenotic lesions in carotid arteries utilizing a single stent, designed to adapt to multiple diameters and to tapered or nontapered configurations. The purpose of this study is to evaluate the conformability and vascular response to a novel stent in a chronic porcine carotid model using serial three-dimensional intravascular ultrasound (IVUS) analysis as well as histological examination. Ten Yucatan pigs underwent stent implantation in both normal carotid arteries with adjunctive balloon angioplasty. Three-dimensional IVUS analysis was performed before stent implantation, after adjunctive balloon angioplasty, and at follow-up [1 month (n = 6), 3 months (n = 6), or 6 months (n = 8)]. Histological examination (injury score, percent plaque obstruction, and qualitative analysis) was also performed. All stents were successfully deployed and well apposed in different sized vessels (lumen area range: 19-30 mm(2)). Volumetric IVUS analysis showed no significant difference between the lumen areas before stent implantation and after adjunctive balloon angioplasty and no stent area change at each follow-up point compared to immediately postprocedure. Histological examination revealed minimal injury and neointimal hyperplasia at each follow-up point. In the chronic porcine carotid model, the novel stent system demonstrated good conformability, resulting in minimal vessel injury and neointimal formation.