STENTYS Completes Enrollment in the Study Assessing the Safety and Efficacy of Xposition S in Left Main Artery Lesions

PARIS., STENTYS, a medical technology company commercializing the Xposition S Sirolimus-eluting self-apposing coronary stent, today announces that the enrollment of the 200 patients for the TRUNC trial has been completed as scheduled.  
Carried out in 18 European clinical sites, the aim of the TRUNC trial is to evaluate the long-term safety and efficacy of the Xposition S stent for the treatment of the unprotected left main artery (the heart’s main artery). Patients will be monitored for up to 2 years following the initial procedure, with the results of the primary endpoint - Target Vessel Failure at 12 months - expected before the end of 2018.

Left main artery lesions, especially within the setting of a heart attack, are characterized by a large artery diameter followed by a substantial tapering on this segment, and also involving a bifurcation in most cases, which makes it very difficult to use conventional balloon-expandable DES. The Xposition S stent is an optimal solution to this issue, thanks to its self-apposing profile that allows the stent to adapt to vessels with varying diameters and perfectly fit even the broadest vessel walls. 

Christophe Lottin, Chief Executive Officer of STENTYS, comments: “I would like to thank all the centers taking part in this trial for meeting this key step of the study as scheduled. Left main artery lesions represent an excellent opportunity to demonstrate that the Xposition S DES is capable of treating particularly complex pathologies and to strengthen our positioning on this segment, which accounts for approximately 10% of all coronary surgical operations worldwide.”  


About the TRUNC study 

TRUNC is a prospective, single-arm multi-center trial to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main lesions in routine clinical practice. It is scheduled to include 200 patients in approximately 20 European clinical sites. The primary endpoint is Target Lesion Failure at 12 months. The trial’s steering committee is composed of Dr. Baumbach (UK), Dr. Briguori (Italy) and Prof. Tamburino (Italy). 

Sources
  • STENTYS

Comments