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INTERVENTIONAL

A Novel Flexible, Retrievable Endovascular Stent System for Small-Vessel Anatomy: Preliminary In Vivo Data

Arnd Doerflera,b, Wolfgang P. H. Beckera, Isabel Wankea, Sophia L. Goerickea, K. M. Muellerc, Nina Blechschmida, Achim Flesserd, Hermann Monstadtd and Michael Forstinga

a Department of Neuroradiology, Institute of Diagnostic and Interventional Radiology, University of Essen Medical School, Essen, Germany
b Department of Neuroradiology, University of Erlangen Medical School, Erlangen
c Department of Pathology, University of Bochum Medical School, Bochum, Germany
d Dendron-MTI, Bochum, Germany

Address correspondence to Arnd Doerfler, MD, Department of Neuroradiology, University of Erlangen Medical School, Schwabachanlage 6, 91054 Erlangen, Germany

BACKGROUND AND PURPOSE: This study assessed the in vivo delivery, retrievability, short-term patency, and cellular response to a new flexible endovascular stent system in a rabbit model. The stent is designed for delivery through a microcatheter and is fully retrievable with electrolytic detachment from a delivery wire.

METHODS: We successfully deployed nine stents (range of sizes, 2.5–4 mm diameter, 15–35 mm length) in six straight (carotid) and three angled (subclavian) arteries of six Chinchilla Bastard rabbits. Serial imaging was performed by using intravenous digital subtraction angiography (IVDSA), contrast-enhanced MR angiography (CEMRA), time-of-flight MR angiography (TOF), and CT-angiography 3 days and 4 weeks after stent deployment. Subjects were euthenized after 4 weeks (n = 5), and stents were removed for histologic analysis.

RESULTS: Stent deployment was feasible in all cases. After initial deployment, all stents could be fully retrieved within the microcatheter. The detachment zone and the distal stent marker were easily visible under fluoroscopy, and final detachment occurred reliably in all cases. We observed no procedural complications. Noninvasive imaging by using IVDSA, MR angiography, and CT angiography was feasible in this stent system and demonstrated all arteries patent and not narrowed at 3 days and 4 weeks, findings that were confirmed by histologic analysis.

CONCLUSION: This electrolytically detachable stent is promising as a treatment for intracranial arteries, because it can be delivered through microcatheters small enough for intracranial navigation. It is fully retrievable, thus providing greater control than currently available stents. Noninvasive imaging by using IVDSA, MR angiography, and CT angiography is feasible in this stent system and may be useful for follow-up. Further long-term data are needed.




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