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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Biotronik AG
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01651390
First received: July 24, 2012
Last updated: January 8, 2014
Last verified: January 2014

July 24, 2012
January 8, 2014
June 2012
December 2014   (final data collection date for primary outcome measure)
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.

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.

Complete list of historical versions of study NCT01651390 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Not Provided
Not Provided
 
Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Coronary Restenosis
  • 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)
  • 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
  • Experimental: Drug coated balloon
    Percutaneous coronary intervention with the Pantera Lux drug coated balloon.
    Intervention: Device: Percutaneous coronary intervention
  • Active Comparator: Drug eluting stent
    Percutaneous coronary intervention with the Orsiro drug eluting stent.
    Intervention: Device: Percutaneous coronary intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
July 2016
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Frank Schmidt +41 44 864 55 14 frank.schmidt@biotronik.com
Contact: Marc Bentele, PhD +41 44 864 55 13 marc.bentele@biotronik.com
Germany,   Latvia
 
NCT01651390
C1105
Yes
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Christoph K Naber, MD Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany
Biotronik AG
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP