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Coronary Artery DiseaseBIOLUX-RCTNCT01651390

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

A study testing Percutaneous coronary intervention in people with Coronary Artery Disease and Coronary Restenosis, run by Biotronik AG at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Coronary Restenosis
What is being tested?
Percutaneous coronary intervention
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
14 sitesin 2 countries
Study dates
Jun 2012to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Germany13 sites

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    Bad Krozingen, 79189

  • Heart Center Segeberger Kliniken

    Bad Segeberg, 23795

  • Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin

    Berlin, 10117

  • Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin

    Berlin, 12203

  • Kardiologie - Angiologie - Pneumologie, Klinikum Coburg

    Coburg, 96450

  • Contilia Heart- and Vascular Center, Elisabeth Krankenhaus

    Essen, 45138

  • Medical Care Center Prof. Mathey, Prof. Schofer

    Hamburg, 22527

  • Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden

    Minden, 32429

  • Klinikum Schwabing

    Munich, 80804

  • LMU - Klinikum der Universität München

    Munich, 81337

  • Klinikum Bogenhausen

    Munich, 81925

  • Universitätsklinikum Münster, Klinik für Kardiologie

    Münster, 48149

  • Innere Medizin III Kardiologie, Kliniken Villingen

    Villingen-Schwenningen, 78050

Other trials in Germany

Latvia1 site

  • Cardiology, Pauls Stradins Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

About this study

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

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.

Read the 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.

Being tested
Percutaneous coronary intervention
Keywords
Restenosis, Drug coated balloon, Drug eluting stent, Paclitaxel, Sirolimus
Medical subject headings
Coronary Artery Disease, Coronary Restenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary interventionDevice

    Also called Pantera Lux drug coated balloon, Paclitaxel, BTHC (Butyryltri-n-hexyl Citrate)

    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.

  • Percutaneous coronary interventionDevice

    Also called Orsiro drug eluting stent, Orsiro hybrid drug eluting stent system, Sirolimus eluting stent

    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.

Study groups in NCT01651390
Study groupRoleWhat they receive
Drug coated balloonExperimentalPercutaneous coronary intervention with the Pantera Lux drug coated balloon.
Receives: Device: Percutaneous coronary intervention
Drug eluting stentActive comparatorPercutaneous coronary intervention with the Orsiro drug eluting stent.
Receives: Device: Percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After 6 months.

Secondary outcomes (9)

  1. 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.

    Measured: After 6 months.

  2. Binary restenosis in-stent and in-segment

    Binary restenosis is defined as ≥50% lumen diameter stenosis as evaluated by offline QCA.

    Measured: After 6 months.

  3. Mean lumen diameter in-stent and in-segment

    Mean minimum lumen diameter derived from two orthogonal views as evaluated by offline QCA.

    Measured: After 6 months.

  4. 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.

    Measured: After 6, 12 and 18 months.

  5. 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).

    Measured: After 6 and 18 months.

  6. 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).

    Measured: After 6, 12 and 18 months.

  7. Stent thrombosis

    According to Academic Research Consortium (ARC) definition (Cutlip et al. Circulation 2007; 115: 2344-2351).

    Measured: After 6, 12 and 18 months.

  8. 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.

    Measured: During hospital stay or 7 days after procedure, whichever came first.

  9. 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.

    Measured: 1 day (During procedure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2015
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01651390
Sponsor's protocol ID
C1105
Acronym
BIOLUX-RCT
Status last verified
Sep 2016
First submitted
24 Jul 2012
Last updated
26 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17470709

  • 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.

    PubMed 10545431

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous coronary intervention in people with Coronary Artery Disease and Coronary Restenosis, run by Biotronik AG at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late lumen loss (in-stent) (time frame: After 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01651390, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2016.

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