Coronary Artery Disease Clinical Trial
Official title:
BIOLUX RCT - Clinical Performance of the Pantera LUX Paclitaxel Releasing Balloon Versus the Drug Eluting Orsiro Hybrid Stent System in Patients With In-stent Restenosis - a Randomized Controlled Trial
To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is angiographically non-inferior to percutaneous intervention with the Orsiro stent 6 months post-procedure.
This clinical investigation is an international, multi-center, randomized controlled trial
with angiographic follow up at 6 months. Clinical follow ups will take place at 6, 12 and 18
months.
Up to 210 subjects will be block randomized 2:1 to receive the Pantera Lux balloon or the
Orsiro stent and will be stratified according to diabetic status at screening.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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