Cappella Announces Initiation of Sideguard 3 Study

November 16, 2009—Cappella, Inc. (Galway, Ireland) announced commencement of Sideguard 3, an intravascular ultrasound/optical coherence tomography evaluation of the company's 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 during the 6-month follow-up period. Gary S. Mintz, MD, and Akiko Maehara, MD, of the Cardiovascular Research Foundation in New York City are the coprincipal investigators for the study.

"The results from the initial CE mark pivotal studies documented positive remodeling," commented Dr. Mintz. "The Sideguard 3 study is intended to provide further certainty for those findings."

Dr. Maehara, who also completed the analysis for the initial study added, "We are looking forward to having more clinical proof of the mechanisms of the remodelling process of nitinol in coronary stents."

Karl-Eugen Hauptmann, MD, recently enrolled the first patients into the study. He is one of the primary German investigators in the Sideguard 3 study and a pioneer in dedicated sidebranch bifurcation stentings. Dr. Hauptmann commented, "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."