Prof Sean Lyden (Cleveland Clinic, Cleveland, OH, US ) discusses the 4-year update from the pivotal trial of a novel paclitaxel-coated percutaneous angioplasty balloon (ILLUMENATE).
Why was the ILLUMENATE study initiated?
What was the study design and what data has been reported to date?
What updates are you giving on ILLUMENATE at LINC 2020?
What conclusions can be made from this data and what questions require further research?
Filmed on location at the Leipzig Interventional Course 2020.
Interviewer: Ashlynne Merrifield
Videographer: Natascha Wienand
Transcript Below :
Question 1 : Why was the ILLUMENATE study initiated?
The ILLUMENATE study was originally initiated to achieve US approval of the Stellarex® drug-coated balloon.
Question 2 : What was the study design and what data has been reported to date?
So, the study design was a two-to-one randomization against plain old balloon angioplasty, looking at patency as well as safety and efficacy.
Question 3 : What updates are you giving on ILLUMENATE at LINC 2020?
So at LINC here, we gave the four-year data, which showed there was no increase in mortality, so continued safety of the Stellarex® product, and continuing to show a patency difference through four years.
Question 4 : What conclusions can be made from this data and what questions require further research?
So the conclusions can be made is this is clearly a safe product with no mortality signal in the last year with the controversy over safety drug-coated balloons. There was a 15% mortality in both the Stellarex® arm and the plain old balloon arm. In terms of what data goes forward as larger sets come out with the Stellarex® programme, hopefully we'll continue to confirm what we saw in the pivotal trial.