Long-term histopathologic and IVUS evaluations of a novel coiled sheet stent in porcine carotid arteries.
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.
Kaneda
Hideaki
H
Division of Cardiovascular Medicine, Stanford University Medical Center, CA 94305, USA.
Ikeno
Fumiaki
F
Lyons
Jennifer
J
Rezaee
Mehrdad
M
Yeung
Alan C
AC
Fitzgerald
Peter J
PJ
D000497:Alloys; D000704:Analysis of Variance; D000800:Angioplasty, Balloon; D000818:Animals; D016893:Carotid Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D005471:Fluoroscopy; D011474:Prosthesis Design; D015607:Stents; D013552:Swine; D018084:Ultrasonography, Interventional
D000497:Alloys; C013616:nitinol