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Clinical Performance of the Pantera Lux DCB Versus the Orsiro DES in Patients With "-Limus" DES-ISR. (BIOLUX-RCT)

This study is currently recruiting participants.
Verified February 2013 by Biotronik AG
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01651390
First received: July 24, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

To determine in a randomized controlled trial whether percutaneous coronary intervention for "-limus" drug eluting stent in-stent restenosis with the Pantera Lux balloon catheter is angiographically non-inferior to percutaneous coronary intervention with the Orsiro stent after 6 months.


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: To Determine in a RCT Whether PCI for "-Limus" DES In-stent Restenosis With the Pantera Lux DCB is Angiographically Non-inferior to PCI With the Orsiro DES After 6 Months.

Resource links provided by NLM:

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 ]

    Late lumen loss is defined as the difference between in-stent respective in-segment 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 quantitative coronary angiography (QCA).

  • 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 quantitative coronary angiography (QCA).

  • Mean lumen diameter in-stent and in-segment [ Time Frame: After 6 months. ] [ Designated as safety issue: No ]
  • 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. Angiographic Patterns of In-Stent Restenosis, Classification and Implications for Long Term Outcome. Circulation 199; 100: 1872-1878) evaluated by offline quantitative coronary angiography (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, coronary artery bypass graft and clinically driven target lesion revascularization.

  • 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.

  • Stent thrombosis [ Time Frame: After 6, 12 and 18 months. ] [ Designated as safety issue: Yes ]
    According to ARC definition (Cutlip et al., Clinical end points in coronary stent trials: a case for standardized definitions, 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 ]

    Device success is defined as

    • successful delivery of the balloon/stent to the target lesion site in the coronary artery and
    • appropriate balloon inflation and deflation or stent deployment and
    • successful removal of the device
    • safe removal of the device in case of deployment failure


Estimated Enrollment: 210
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (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

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.

Dual antiplatelet therapy (DAPT) for 3 months.

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

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.

Dual antiplatelet therapy (DAPT) for 6 months.

Other Names:
  • Orsiro drug eluting stent
  • Orsiro hybrid drug eluting stent system
  • Sirolimus eluting stent

Detailed Description:

A prospective, multicenter, international, non-inferiority randomized controlled clinical trial. 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.

Subjects treated with the Pantera Lux balloon will have a dual antiplatelet therapy for 3 months whereas subjects treated with the Orsiro stent will have a dual antiplatelet therapy for 6 months.

All patients will undergo an angiography after 6 months. Patients are clinically followed up after 3, 6, 12 and 18 months.

  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 a single in-stent restenotic lesion in a "-limus" drug eluting stent (sirolimus, everolimus, zotarolimus, biolimus): First reoccurrence of a single lesion after implantation of a "-limus" drug eluting stent to treat a de novo lesion
  7. Subject must have no more than two lesions requiring treatment during BIOLUX RCT index procedure. These lesions must be in different vessel distributions. For example, if one target lesion is in the LAD, then the second target lesion must be present in either the LCX or RCA. The second lesion may not be in a branch vessel or distal to the target vessel location
  8. Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
  9. Target lesion length (visual estimation): ≥ 8.0 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 any vessel must be completed latest 30 days before BIOLUX RCT index procedure(s)
  2. Subjects with a present dual antiplatelet therapy (DAPT) lasting longer than 90 days post BIOLUX RCT index procedure(s). This includes subjects taking phenprocoumon, warfarin or similar drugs.
  3. Additional coronary lesions (restenotic or de novo) in the same vessel(s) or in a different coronary vessel which requires treatment within the next 18 months
  4. Evidence of acute ST-segment-elevation myocardial infarction within 72 hours prior to index procedure according to the universal definition of myocardial infarction
  5. Subjects with acute cardiac decompensation or acute cardiogenic shock
  6. Subject with a life expectancy of less than 18 months
  7. In the investigators opinion subject who will not be able to comply with the follow up requirements
  8. 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)
  9. Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)
  10. Thrombus in the target vessel
  11. Target lesion involves a side branch > 2.0 mm in diameter
  12. Target lesion located in left main coronary artery
  13. Documented left ventricular ejection fraction (LVEF) ≤ 30%
  14. 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
  15. 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)
  16. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
  17. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651390

Contacts
Contact: Marc Bentele, PhD +41 44 864 55 13 marc.bentele@biotronik.com
Contact: Dianne Egli-Gany, Msc +41 44 864 58 66 dianne.egli-gany@biotronik.com

Locations
Germany
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: Bernhard Witzenbichler, MD     +49 30 84 45 23 49     bernhard.witzenbichler@charite.de    
Principal Investigator: Bernhard Witzenbichler, MD            
Sub-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     johannes.brachmann@klinikum-coburg.de    
Principal Investigator: Johannes Brachmann, MD            
Sub-Investigator: Barbara Blüm, MD            
Sub-Investigator: Manfred Dücker, MD            
Sub-Investigator: Wolfgang Hohenforst-Schmidt, MD            
Sub-Investigator: Stefan Holzmann, MD            
Sub-Investigator: Kai Kögler, MD            
Sub-Investigator: Harald Pless, MD            
Sub-Investigator: Steffen Schnupp, MD            
Contilia Heart- and Vascular Center, Elisabeth Krankenhaus Recruiting
Essen, Germany, 45138
Contact: Christoph K Naber, MD     +49 20 18 97 32 07     c.k.naber@contilia.de    
Principal Investigator: Christoph Naber, MD            
Sub-Investigator: Thomas Schmitz, MD            
Sub-Investigator: Karsten Meuter, MD            
Sub-Investigator: Jürgen Kolditz, MD            
Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden Recruiting
Minden, Germany, 32429
Contact: Marcus Wiemer, MD     +49 571 790 31 01     marcus.wiemer@muehlenkreiskliniken.de    
Principal Investigator: Marcus Wiemer, MD            
Sub-Investigator: Christian Heer, MD            
Sub-Investigator: Söhnke 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            
Sub-Investigator: Johannes Waltenberger, MD            
Innere Medizin III Kardiologie, Kliniken Villingen Recruiting
Villingen-Schwenningen, Germany, 78050
Contact: Werner Jung, MD     +49 7721 93 30 01     imk@sbk-vs.de    
Principal Investigator: Werner Jung, MD            
Sub-Investigator: Kai Oppenländer, MD            
Sub-Investigator: Dirk Hildebrandt, MD            
Sub-Investigator: Bajram Hajredini, MD            
Latvia
Cardiology, Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, LV-1002
Contact: Andrejs Erglis, MD     +371 67 06 94 79     a.a.erglis@stradini.lv    
Principal Investigator: Andrejs Erglis, MD            
Sub-Investigator: Inga Narbute, MD            
Sub-Investigator: Karlis Trusinskis, MD            
Sub-Investigator: Indulis Kumsars, MD            
Sub-Investigator: Aigars Lismanis, MD            
Sub-Investigator: Sanda Jegere, MD            
Sub-Investigator: Gustavs Latkovskis, MD            
Sub-Investigator: Ainars Rudzitis, MD            
Sub-Investigator: Andis Dombrovskis, MD            
Sub-Investigator: Dace Sondore, MD            
Sub-Investigator: Rabih Hamadi, MD            
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 14, 2013
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
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
Myocardial Ischemia
Coronary Disease
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Stenosis
Sirolimus
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013