MedAlliance today announced first patient enrolment in the coronary randomised controlled study SELUTION DeNovo. This study utilises Selution SLR, a novel sirolimus drug-eluting balloon (DEB), versus a limus drug-eluting stent (DES).
According to MedAlliance, this is the largest DEB study ever initiated, with over 3,300 patients to be enrolled at approximately 50 sites in 15 countries. Patients are randomised before any vessel preparation to reflect current medical practice and to reduce bias. The objectives of the study are to demonstrate, at both one and five years, non-inferiority and subsequently superiority for target vessel failure (TVF).
This study is designed to change medical practice, a press release reports, as the majority of de novo coronary vessels are currently treated with a permanent metallic stent. The Selution SLR elutes sirolimus for over 90 days, similar to a DES, but without leaving behind a metal scaffold, which has been associated with a complication rate of 2% annually.
“We are pleased to participate in a robust prospective randomised study, working with some of the leading institutions and operators in the world to answer these important questions for patients and physicians alike”, commented principal investigator Juan F Iglesias (Geneva University Hospitals, Geneva, Switzerland). “We are excited to be the first enrolling centre in this important study. Initial use of this novel DEB has demonstrated a high level of deliverability, especially in small vessels and side branches”.
“This study is the largest, most ambitious study ever initiated to understand the patient benefit of a DEB versus the latest generation DES. We hope to demonstrate that limus DEB can replace DES in most coronary de novo lesions, just as limus DES replaced paclitaxel DES”, added Jeffrey B Jump, chairman and CEO of MedAlliance.