Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent

Abstract

The first clinical results showed a safe implantation behavior without the occurrence of any ischemia. The structure of the new CASPER-RX stent creates an acceptable flexibility, low radial force, and high collapse pressure. The large foreshortening during implantation should be considered as well as the higher bending stiffness, especially when used in elongated carotid arteries.

Commentary: Carotid Artery Revascularization for Stroke Prevention

“…The article by Wissgott et al 62 on the carotid CGuard double-layered embolic prevention stent in the February 2017 issue of the JEVT represents the journal's most recent contribution to the cutting-edge developments in CAS that has included dual-layer stent technology [63][64][65] and new data on the evolution of intraprocedural cerebral protection. 58,66 Following on their work with the RoadSaver doublelayer stent [Terumo, Tokyo, Japan; branded as Casper for commercialization in neuroradiology by Microvention/ Terumo, Saint-Germain-en-Laye, France), 65 Wissgott and colleagues 62 continue their work by evaluating another major dual-layer stent: the CGuard embolic prevention stent (EPS) system (InspireMD, Boston, MA, USA).…”

“…58,66 Following on their work with the RoadSaver doublelayer stent [Terumo, Tokyo, Japan; branded as Casper for commercialization in neuroradiology by Microvention/ Terumo, Saint-Germain-en-Laye, France), 65 Wissgott and colleagues 62 continue their work by evaluating another major dual-layer stent: the CGuard embolic prevention stent (EPS) system (InspireMD, Boston, MA, USA). As in their prior work, they provide a thorough evaluation of the mechanical properties of the new prevention stent.…”

“…Finally, the position of the mesh in relation to the nitinol frame varies: outside the frame for the CGuard EPS and Gore stent and inside in the case of the RoadSaver/Casper. 61,62,65,67 The RoadSaver/Casper stent delivery system is low profile and very flexible. Similar to the Wallstent, it is resheathable up to 50% of the released stent length, which may offer a procedural advantage to some operators.…”

“…Design differences among the dual-layered stent systems translate into individual differences in their mechanical properties, 62,65 some of which may be significant from standpoints of procedure strategy and operator preference. It remains to be determined, however, whether these differing stent design and mechanical properties are important in terms of clinical safety and efficacy (eg, the risk of stent thrombosis or restenosis).…”

“…RoadSaver/Casper has 2 nitinol layers, with the nitinol mesh layer positioned inside the nitinol frame of the stent, forming a "distance" that requires endothelialization for complete stent healing (at the strut crossing point 180 µm + 180 µm + 42 µm of the wire mesh + any malapposition distance if present 65 ). Animal evidence on RoadSaver/Casper healing in 12 pigs indicated no evidence of restenosis at 6 months.…”