Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis. (BIOLUX-RCT)
Primary Purpose
Coronary Artery Disease, Coronary Restenosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Restenosis, Drug coated balloon, Drug eluting stent, Paclitaxel, Sirolimus
Eligibility Criteria
Inclusion Criteria:
- Subject has provided a written informed consent
- Subject ≥ 18 years
- Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
- Subject eligible for percutaneous coronary intervention
- Subject acceptable candidate for coronary artery bypass surgery
- Subject with an in-stent restenotic lesion* in either a bare metal stent or drug eluting stents (Mehran class I, II, III, IV - Mehran et al. Circulation 199; 100: 1872-1878). *Target lesion
- Subjects with a maximum of 2 target lesions. In case of 2 target lesions, both lesions must be either in bare metal stents or drug eluting stents, and must treated during the same session with the same type of device as per randomization outcome, e.g. drug eluting stent.
- Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
- Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm
- Target lesion stenosis (visual estimation): > 50 % and ≤ 100 %
- Target lesion in a native coronary artery
Exclusion Criteria:
- Planned (staged) interventional treatment in the same vessel(s) as the target lesion(s) within 30 days pre- and/or post BIOLUX RCT index procedure.
- Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction
- Subjects with acute cardiac decompensation or acute cardiogenic shock
- Subject with a life expectancy of less than 18 month
- In the investigators opinion subject who will not be able to comply with the follow up requirements
- Impaired renal function (excluded are subjects in need of dialysis or subjects with a creatinine level ≥ 221 µmol per liter (2.5 mg per deciliter) within 72 hours of the intended treatment)
- Thrombus in the target vessel
- Target lesion located in left main coronary artery
- Documented left ventricular ejection fraction (LVEF) ≤ 30%
- Known allergies to: acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT 578, biolimus, tacrolimus); CoCr, PLLA, silicon carbide
- Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
- Previously enrolled in this trial
Sites / Locations
- Universitäts-Herzzentrum Freiburg-Bad Krozingen
- Heart Center Segeberger Kliniken
- Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin
- Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin
- Kardiologie - Angiologie - Pneumologie, Klinikum Coburg
- Contilia Heart- and Vascular Center, Elisabeth Krankenhaus
- Medical Care Center Prof. Mathey, Prof. Schofer
- Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden
- Klinikum Schwabing
- LMU - Klinikum der Universität München
- Klinikum Bogenhausen
- Universitätsklinikum Münster, Klinik für Kardiologie
- Innere Medizin III Kardiologie, Kliniken Villingen
- Cardiology, Pauls Stradins Clinical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Drug coated balloon
Drug eluting stent
Arm Description
Percutaneous coronary intervention with the Pantera Lux drug coated balloon.
Percutaneous coronary intervention with the Orsiro drug eluting stent.
Outcomes
Primary Outcome Measures
Late lumen loss (in-stent)
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).
In-stent:
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.
Secondary Outcome Measures
Percent diameter stenosis in-stent and in-segment
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.
In-segment:
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
Binary restenosis is defined as ≥50% lumen diameter stenosis as evaluated by offline QCA.
Mean lumen diameter in-stent and in-segment
Mean minimum lumen diameter derived from two orthogonal views as evaluated by offline QCA.
Type of reoccurrence according to Mehran classification
Type of reoccurrence according to Mehran classification (Mehran et al. Circulation 199; 100: 1872-1878) evaluated by offline QCA.
Target lesion failure (TLF)
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)
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
According to Academic Research Consortium (ARC) definition (Cutlip et al. Circulation 2007; 115: 2344-2351).
Procedure success
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01651390
Brief Title
Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
Acronym
BIOLUX-RCT
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Restenosis
Keywords
Restenosis, Drug coated balloon, Drug eluting stent, Paclitaxel, Sirolimus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug coated balloon
Arm Type
Experimental
Arm Description
Percutaneous coronary intervention with the Pantera Lux drug coated balloon.
Arm Title
Drug eluting stent
Arm Type
Active Comparator
Arm Description
Percutaneous coronary intervention with the Orsiro drug eluting stent.
Intervention Type
Device
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
Pantera Lux drug coated balloon, Paclitaxel, BTHC (Butyryltri-n-hexyl Citrate)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
Orsiro drug eluting stent, Orsiro hybrid drug eluting stent system, Sirolimus eluting stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Late lumen loss (in-stent)
Description
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).
In-stent:
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.
Time Frame
After 6 months.
Secondary Outcome Measure Information:
Title
Percent diameter stenosis in-stent and in-segment
Description
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.
In-segment:
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.
Time Frame
After 6 months.
Title
Binary restenosis in-stent and in-segment
Description
Binary restenosis is defined as ≥50% lumen diameter stenosis as evaluated by offline QCA.
Time Frame
After 6 months.
Title
Mean lumen diameter in-stent and in-segment
Description
Mean minimum lumen diameter derived from two orthogonal views as evaluated by offline QCA.
Time Frame
After 6 months.
Title
Type of reoccurrence according to Mehran classification
Description
Type of reoccurrence according to Mehran classification (Mehran et al. Circulation 199; 100: 1872-1878) evaluated by offline QCA.
Time Frame
After 6, 12 and 18 months.
Title
Target lesion failure (TLF)
Description
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).
Time Frame
After 6 and 18 months.
Title
Target vessel failure (TVF)
Description
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).
Time Frame
After 6, 12 and 18 months.
Title
Stent thrombosis
Description
According to Academic Research Consortium (ARC) definition (Cutlip et al. Circulation 2007; 115: 2344-2351).
Time Frame
After 6, 12 and 18 months.
Title
Procedure success
Description
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.
Time Frame
During hospital stay or 7 days after procedure, whichever came first.
Title
Device success
Description
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.
Time Frame
1 day (During procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has provided a written informed consent
Subject ≥ 18 years
Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
Subject eligible for percutaneous coronary intervention
Subject acceptable candidate for coronary artery bypass surgery
Subject with an in-stent restenotic lesion* in either a bare metal stent or drug eluting stents (Mehran class I, II, III, IV - Mehran et al. Circulation 199; 100: 1872-1878). *Target lesion
Subjects with a maximum of 2 target lesions. In case of 2 target lesions, both lesions must be either in bare metal stents or drug eluting stents, and must treated during the same session with the same type of device as per randomization outcome, e.g. drug eluting stent.
Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm
Target lesion stenosis (visual estimation): > 50 % and ≤ 100 %
Target lesion in a native coronary artery
Exclusion Criteria:
Planned (staged) interventional treatment in the same vessel(s) as the target lesion(s) within 30 days pre- and/or post BIOLUX RCT index procedure.
Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction
Subjects with acute cardiac decompensation or acute cardiogenic shock
Subject with a life expectancy of less than 18 month
In the investigators opinion subject who will not be able to comply with the follow up requirements
Impaired renal function (excluded are subjects in need of dialysis or subjects with a creatinine level ≥ 221 µmol per liter (2.5 mg per deciliter) within 72 hours of the intended treatment)
Thrombus in the target vessel
Target lesion located in left main coronary artery
Documented left ventricular ejection fraction (LVEF) ≤ 30%
Known allergies to: acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT 578, biolimus, tacrolimus); CoCr, PLLA, silicon carbide
Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
Previously enrolled in this trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph K Naber, MD
Organizational Affiliation
Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Herzzentrum Freiburg-Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Heart Center Segeberger Kliniken
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Kardiologie - Angiologie - Pneumologie, Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Contilia Heart- and Vascular Center, Elisabeth Krankenhaus
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Medical Care Center Prof. Mathey, Prof. Schofer
City
Hamburg
ZIP/Postal Code
22527
Country
Germany
Facility Name
Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Klinikum Schwabing
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
LMU - Klinikum der Universität München
City
Munich
ZIP/Postal Code
81337
Country
Germany
Facility Name
Klinikum Bogenhausen
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Kardiologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Innere Medizin III Kardiologie, Kliniken Villingen
City
Villingen-Schwenningen
ZIP/Postal Code
78050
Country
Germany
Facility Name
Cardiology, Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17470709
Citation
Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
Results Reference
background
PubMed Identifier
10545431
Citation
Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872.
Results Reference
background
Learn more about this trial
Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
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