Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis. (BIOLUX-RCT)
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.
Coronary Artery Disease
Device: Percutaneous coronary intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||December 2014 (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
|Contact: Frank Schmidt||+41 44 864 55 email@example.com|
|Contact: Marc Bentele, PhD||+41 44 864 55 firstname.lastname@example.org|
|Universitäts-Herzzentrum Freiburg-Bad Krozingen||Recruiting|
|Bad Krozingen, Germany, 79189|
|Contact: Franz-Josef Neumann, MD +49 76 33 40 22 001 Franz-Josef.Neumann@universitaets-herzzentrum.de|
|Principal Investigator: Franz-Josef Neumann, MD|
|Sub-Investigator: Christian Valina, MD|
|Sub-Investigator: Nikolaus Löffelhardt, MD|
|Sub-Investigator: Thomas Comberg, MD|
|Sub-Investigator: Miroslaw Ferenc, MD|
|Sub-Investigator: Michael Gick, MD|
|Sub-Investigator: Gregor Leibundgut, MD|
|Sub-Investigator: Jürgen Rothe, MD|
|Heart Center Segeberger Kliniken||Recruiting|
|Bad Segeberg, Germany, 23795|
|Contact: Gert Richardt, MD +49 45 51 80 24 801 email@example.com|
|Principal Investigator: Gert Richardt, MD|
|Sub-Investigator: Mohamed Abdel-Wahad, MD|
|Sub-Investigator: Ken Gordian, MD|
|Sub-Investigator: Constanze Merten, MD|
|Sub-Investigator: Bettina Schwarz, MD|
|Sub-Investigator: Björn Stöcker, MD|
|Sub-Investigator: Ralph Tölg, MD|
|Sub-Investigator: Volker Geist, MD|
|Sub-Investigator: Dmitry Sulimov, MD|
|Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin||Recruiting|
|Berlin, Germany, 10117|
|Contact: Karl Stangl, MD +49 30 450 51 31 42 Karl.Stangl@charite.de|
|Principal Investigator: Karl Stangl, MD|
|Sub-Investigator: Verena Stangl, MD|
|Sub-Investigator: Martin Möckel, MD|
|Sub-Investigator: Henryk Dreger, MD|
|Sub-Investigator: Michael Laule, MD|
|Sub-Investigator: Wasiem Sanad, MD|
|Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin||Recruiting|
|Berlin, Germany, 12203|
|Contact: Michael Gross, MD +49 30 84 45 45 95 firstname.lastname@example.org|
|Principal Investigator: Michael Gross, MD|
|Sub-Investigator: Carsten Skurk, MD|
|Kardiologie - Angiologie - Pneumologie, Klinikum Coburg||Recruiting|
|Coburg, Germany, 96450|
|Contact: Johannes Brachmann, MD +49 95 61 22 63 98 email@example.com|
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|Sub-Investigator: Stefan Holzmann, MD|
|Sub-Investigator: Kai Kögler, MD|
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|Contilia Heart- and Vascular Center, Elisabeth Krankenhaus||Recruiting|
|Essen, Germany, 45138|
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|Sub-Investigator: Alexander Wolf, MD|
|Medical Care Center Prof. Mathey, Prof. Schofer||Recruiting|
|Hamburg, Germany, 22527|
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|Principal Investigator: Joachim Schofer, MD|
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|Sub-Investigator: Steffen Brucks, MD|
|Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden||Recruiting|
|Minden, Germany, 32429|
|Contact: Marcus Wiemer, MD +49 571 790 31 01 firstname.lastname@example.org|
|Principal Investigator: Marcus Wiemer, MD|
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|Sub-Investigator: Söhnke Theiss, MD|
|Munich, Germany, 81925|
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|Principal Investigator: Johannes Rieber, MD|
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|Sub-Investigator: Peter Christian Landwehr, MD|
|Klinikum Schwabing||Not yet recruiting|
|Munich, Germany, 80804|
|Contact: Stefan Sack, MD +49 89 30 68 25 25 firstname.lastname@example.org|
|Principal Investigator: Stefan Sack, MD|
|Sub-Investigator: Jochen Menne, MD|
|LMU - Klinikum der Universität München||Recruiting|
|Munich, Germany, 81337|
|Contact: Julinda Mehilli, MD +49 89 7095 2361 Julinda.Mehilli@med.uni-muenchen.de|
|Principal Investigator: Julinda Mehilli, MD|
|Sub-Investigator: Hans Diogenes Theiss, MD|
|Universitätsklinikum Münster, Klinik für Kardiologie||Recruiting|
|Münster, Germany, 48149|
|Contact: Dieter Fischer, MD +49 251 834 50 78 Dieter.Fischer@ukmuenster.de|
|Principal Investigator: Dieter Fischer, MD|
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|Innere Medizin III Kardiologie, Kliniken Villingen||Recruiting|
|Villingen-Schwenningen, Germany, 78050|
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|Principal Investigator: Werner Jung, MD|
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|Sub-Investigator: Bajram Hajredini, MD|
|Cardiology, Pauls Stradins Clinical University Hospital||Recruiting|
|Riga, Latvia, LV-1002|
|Contact: Andrejs Erglis, MD +371 67 06 94 79 firstname.lastname@example.org|
|Principal Investigator: Andrejs Erglis, MD|
|Sub-Investigator: Inga Narbute, MD|
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|Sub-Investigator: Indulis Kumsars, MD|
|Sub-Investigator: Aigars Lismanis, MD|
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|Sub-Investigator: Ainars Rudzitis, MD|
|Sub-Investigator: Andis Dombrovskis, MD|
|Sub-Investigator: Dace Sondore, MD|
|Sub-Investigator: Rabih Hamadi, MD|
|Principal Investigator:||Christoph K Naber, MD||Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany|