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Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis. (BIOLUX-RCT)

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ClinicalTrials.gov Identifier: NCT01651390
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Restenosis Device: Percutaneous coronary intervention Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
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
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : July 2016
Arms and Interventions
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Arm Intervention/treatment
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.
Other Names:
  • Pantera Lux drug coated balloon
  • Paclitaxel
  • BTHC (Butyryltri-n-hexyl Citrate)
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.
Other Names:
  • Orsiro drug eluting stent
  • Orsiro hybrid drug eluting stent system
  • Sirolimus eluting stent


Outcome Measures
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Primary Outcome Measures :
  1. 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).

    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 :
  1. 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.

    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.


  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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.

  9. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has provided a written informed consent
  2. Subject ≥ 18 years
  3. Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
  4. Subject eligible for percutaneous coronary intervention
  5. Subject acceptable candidate for coronary artery bypass surgery
  6. 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
  7. 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.
  8. Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
  9. Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm
  10. Target lesion stenosis (visual estimation): > 50 % and ≤ 100 %
  11. Target lesion in a native coronary artery

Exclusion Criteria:

  1. 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.
  2. Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction
  3. Subjects with acute cardiac decompensation or acute cardiogenic shock
  4. Subject with a life expectancy of less than 18 month
  5. In the investigators opinion subject who will not be able to comply with the follow up requirements
  6. 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)
  7. Thrombus in the target vessel
  8. Target lesion located in left main coronary artery
  9. Documented left ventricular ejection fraction (LVEF) ≤ 30%
  10. 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
  11. 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)
  12. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
  13. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
  14. Previously enrolled in this trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651390


Locations
Germany
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
Klinikum Schwabing
Munich, Germany, 80804
LMU - Klinikum der Universität München
Munich, Germany, 81337
Klinikum Bogenhausen
Munich, Germany, 81925
Universitätsklinikum Münster, Klinik für Kardiologie
Münster, Germany, 48149
Innere Medizin III Kardiologie, Kliniken Villingen
Villingen-Schwenningen, Germany, 78050
Latvia
Cardiology, Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Christoph K Naber, MD Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany
More Information
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Publications:

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01651390     History of Changes
Other Study ID Numbers: C1105
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Biotronik AG:
Restenosis
Drug coated balloon
Drug eluting stent
Paclitaxel
Sirolimus

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Paclitaxel
Albumin-Bound Paclitaxel
Sirolimus
Everolimus
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs