Cappella, developing devices for the treatment of coronary artery disease, has started Sideguard 3, an IVUS/OCT evaluation of the Sideguard Coronary Sidebranch Stent and Delivery System. This is a European multicenter study to evaluate the vascular response to Sideguard in de novo bifurcation lesions of native coronary arteries. The primary objective of the study is to determine the change in stent area (mm2) and corresponding change in vessel area (mm2) at the carina of the sidebranch.
“The results from the initial CE mark pivotal studies documented positive remodelling. The Sideguard 3 study is intended to provide further certainty for those findings.” said Gary S. Mintz. Further, Akiko Maehara, who also completed the analysis for the initial study said: “We are looking forward to having more clinical proof of the mechanisms of the remodelling process of nitinol in coronary stents.” Gary S. Mintz, MD, & Akiko Maehara, MD, Cardiovascular Research Foundation, New York, USA, are the co-PIs for the study.
One of the primary German investigators in the Sideguard 3 study and pioneer in dedicated sidebranch bifurcation stenting, Karl-Eugen Hauptmann, MD, Krankenhaus der Barmherzigen Brueder in Trier, Germany, stated: “Sideguard is my stent of choice for the treatment of bifurcation lesions. I am very happy to continue my close collaboration with Cappella in this interesting clinical trial.” Karl-Eugen Hauptmann has recently enrolled the first patients into the study.