Project

LEADERS FREE III

Completed ยท 2017 until 2021

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2017
End Date
2021
Financing
Industry
Study Design
Prospective, multi-center, open-label single-arm study designed to enroll 370 patients at up to 20 Centers. All patients will be followed up for 2 years.
Keywords
CAD, Stent
Brief description/objective

A study evaluating the safety and efficacy of the BioFreedomTM Biolimus A9TM coated Cobalt Chromium coronary stent system in patients at high risk of bleeding.
The objective of this study is to evaluate if the BioFreedomTM CoCr Drug Coated stent has a similar clinical safety and efficacy characteristics to the BioFreedomTM SS Drug Coated stent.
Primary Safety Endpoint: MACE, defined as a composite of cardiac death, MI and definite/probable ST at one year.
Primary Efficacy Endpoint: Clinically driven target lesion revascularization (TLR) at one year.