Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis. (BIOLUX-RCT)
|Coronary Artery Disease Coronary Restenosis||Device: Percutaneous coronary intervention|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Late lumen loss (in-stent) [ Time Frame: After 6 months. ]
In-stent late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).
Pantera Lux balloon: In-stent is defined as from (proximal) shoulder to (distal) shoulder of the dilated balloon.
Orsiro stent: In-stent is defined as from (proximal) edge to (distal) edge of the implanted Orsiro stent.
- Percent diameter stenosis in-stent and in-segment [ Time Frame: After 6 months. ]
Percent diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%. Angiographic parameters as evaluated by offline QCA.
Pantera Lux balloon: In-segment is defined as in-stent plus 5 mm distal and 5 mm proximal.
Orsiro stent: In-segment is defined as in-stent plus 5 mm distal and 5 mm proximal.
- Binary restenosis in-stent and in-segment [ Time Frame: After 6 months. ]Binary restenosis is defined as ≥50% lumen diameter stenosis as evaluated by offline QCA.
- Mean lumen diameter in-stent and in-segment [ Time Frame: After 6 months. ]Mean minimum lumen diameter derived from two orthogonal views as evaluated by offline QCA.
- Type of reoccurrence according to Mehran classification [ Time Frame: After 6, 12 and 18 months. ]Type of reoccurrence according to Mehran classification (Mehran et al. Circulation 199; 100: 1872-1878) evaluated by offline QCA.
- Target lesion failure (TLF) [ Time Frame: After 6 and 18 months. ]TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).
- Target vessel failure (TVF) [ Time Frame: After 6, 12 and 18 months. ]TVF is defined as a composite of cardiac death, any target vessel myocardial infarction, coronary artery bypass graft and clinically driven target vessel revascularization (TVR).
- Stent thrombosis [ Time Frame: After 6, 12 and 18 months. ]According to Academic Research Consortium (ARC) definition (Cutlip et al. Circulation 2007; 115: 2344-2351).
- Procedure success [ Time Frame: During hospital stay or 7 days after procedure, whichever came first. ]Procedure success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay or 7 days after procedure, whichever came first.
- Device success [ Time Frame: 1 day (During procedure) ]Successful delivery of the balloon or stent to the target lesion site in the coronary artery; and appropriate balloon inflation and deflation or stent deployment; and successful removal of the balloon or the delivery system.
|Study Start Date:||June 2012|
|Study Completion Date:||July 2016|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Drug coated balloon
Percutaneous coronary intervention with the Pantera Lux drug coated balloon.
Device: Percutaneous coronary intervention
Up to 140 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Pantera Lux drug coated balloon.
Active Comparator: Drug eluting stent
Percutaneous coronary intervention with the Orsiro drug eluting stent.
Device: Percutaneous coronary intervention
Up to 70 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Orsiro drug eluting stent.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651390
|Universitäts-Herzzentrum Freiburg-Bad Krozingen|
|Bad Krozingen, Germany, 79189|
|Heart Center Segeberger Kliniken|
|Bad Segeberg, Germany, 23795|
|Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin|
|Berlin, Germany, 10117|
|Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin|
|Berlin, Germany, 12203|
|Kardiologie - Angiologie - Pneumologie, Klinikum Coburg|
|Coburg, Germany, 96450|
|Contilia Heart- and Vascular Center, Elisabeth Krankenhaus|
|Essen, Germany, 45138|
|Medical Care Center Prof. Mathey, Prof. Schofer|
|Hamburg, Germany, 22527|
|Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden|
|Minden, Germany, 32429|
|Munich, Germany, 80804|
|LMU - Klinikum der Universität München|
|Munich, Germany, 81337|
|Munich, Germany, 81925|
|Universitätsklinikum Münster, Klinik für Kardiologie|
|Münster, Germany, 48149|
|Innere Medizin III Kardiologie, Kliniken Villingen|
|Villingen-Schwenningen, Germany, 78050|
|Cardiology, Pauls Stradins Clinical University Hospital|
|Riga, Latvia, LV-1002|
|Principal Investigator:||Christoph K Naber, MD||Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany|