Project

TRUNC - Multicenter prospective study of the STENTYS Xposition S for treatment of unprotected Left Main Coronary Artery Disease

Completed ยท 2016 until 2019

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2016
End Date
2019
Financing
Industry
Study Design
Prospective, non-randomized, single-blind, multi-center study.
Keywords
Coronary Artery Disease Main branch
Brief description/objective

To assess the long-term safety and efficacy of the Xposition S stent (self-expanding sirolimus-eluting stent with a durable polymer coating) in the treatment of unprotected left main coronary artery disease.
Primary clinical endpoint:
Target Lesion Failure at 12 months post-procedure. TLF is defined as cardiac death, Myocardial Infarction (MI, WHO Extended Definition) not attributable to a non-target vessel, or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
Primary efficacy endpoint:
Angiographic success: placement of the stent as intended at the target lesion with achievement of <20% final residual stenosis of the target lesion (mean along the target lesion length (main branch) determined by visual estimation), with TIMI 3 flow in main branch.