MedAlliance’s Large-Scale SELUTION DeNovo Study Enrollment Reaches Halfway Point

September 14, 2023—MedAlliance announced an update of patient enrollment in the SELUTION DeNovo coronary randomized study, which is comparing a treatment strategy using the company’s Selution SLR sirolimus drug-eluting balloon versus any limus drug-eluting stent (DES).

According to the company, with 1,660 patients, recruitment is now halfway towards a planned 3,326-patient enrollment. In March, MedAlliance announced that enrollment had reached 1,000 patients. The study commenced in 2021 and involves up to 70 participating sites in 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias.

The objectives of the study are to demonstrate noninferiority at both 1 and 5 years, and superiority for target vessel failure at 5 years.

“This is a major milestone for the SELUTION DeNovo trial, as it is now the largest DEB study ever conducted,” commented Coprincipal Investigator Professor Christian Spaulding, MD, in the MedAlliance press release.

Prof. Spaulding, who is with the Cardiology Department, European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris and Paris Cité University in Paris, France, continued, “The study is performed in a true all-comers population and is not just looking at small vessel artery disease. It is encouraging that the Drug and Safety Monitoring Board has no concerns, voting unanimously for the trial to continue as planned, as there are no worrying protocol deviations and no significant differences between the groups. We see investigators being comfortable using this novel approach and expect the enrollment to be completed within the next 12 months.”