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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01651390
First received: July 24, 2012
Last updated: February 2, 2015
Last verified: February 2015
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
Coronary Restenosis
 Device: Percutaneous coronary intervention

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • 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).

    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 [ 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.

    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 [ 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.
Enrollment: 231
Study Start Date: June 2012
Estimated Study Completion Date: August 2016
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651390

Locations
Germany
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, Germany, 79189
Heart Center Segeberger Kliniken
Bad Segeberg, Germany, 23795
Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin
Berlin, Germany, 12203
Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin
Berlin, Germany, 10117
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
LMU - Klinikum der Universität München
Munich, Germany, 81337
Klinikum Schwabing
Munich, Germany, 80804
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

Publications:

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01651390     History of Changes
Other Study ID Numbers: C1105
Study First Received: July 24, 2012
Last Updated: February 2, 2015
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection
Latvia: Institutional Review Board
Latvia: State Agency of Medicines

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

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Restenosis
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
 Coronary Disease
Coronary Stenosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015