CClinicalTrials.gg
Status unknownNCT01930903PaneLux PTCAUpdated Apr 30, 2015

PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon

An interventional study of Pantera Lux Drug Eluting Balloon in Coronary Artery Disease and High Bleeding Risk Patients, sponsored by Biotronik France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-30.

Sponsored by Biotronik France · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.

02

Conditions studied

  • Coronary Artery Disease
  • High Bleeding Risk Patients

Keywords

  • PRO-Kinetic Energy BMS + Pantera Lux DEB combination
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 500 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Biotronik France is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject has provided a written informed consent
  2. Subject >/= 18 years.
  3. Patient affiliated to social security
  4. Patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months)
  5. Subject eligible for percutaneous coronary intervention AND undergoing a chronical oral anticoagulant treatment OR undergoing any semi-urgent invasive or non cardiac surgical planned intervention with major bleeding risks
  6. Subject eligible for Dual Anti Platelet Therapy (DAPT) of acetyl salicylic acid and clopidogrel for at least 3 weeks
  7. De Novo coronary lesions: >/= 50% - \<100%
  8. Subject, vessels and target lesion eligible for angioplasty with PRO-Kinetic Energy stent implantation and final post-dilatation with Pantera Lux drug eluting balloon.
  9. Target lesion length \</= 26 mm , visual estimation or by Quantitative Coronary Angiography (QCA)
  10. Reference diameters targeted vessels >/=2.5mm and \</= 4.0 mm (visual estimation or QCA)

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
  2. Subject with a life expectancy less than 1 year
  3. Vulnerable subject, protected by law, unable to give his/her consent
  4. Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
  5. Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
  6. Subject under chronical oral anti-coagulant treatment (optionnal indication)
  7. Subject undergoing any urgent invasive or surgical intervention with major bleeding risk, which can not maintain dual anti-platelet therapy (DAPT) for at least 3 weeks
  8. In stent restenotic lesion
  9. Target lesion on vessels with nominal diameter \< 2.5 mm
  10. Target lesion is located in or supplied by an arterial or venous bypass graft
  11. Chronical Total occlusion (CTO)
  12. Angioplasty indication for STEMI
  13. Patient with signs of cardiogenic shock
  14. Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
  15. "Staged procedure" > 8 days after the initial angioplasty
  16. Documented left ventricular ejection fraction (LVEF) \</= 30%
  17. Target lesion requiring before stent implantation a device other than a pre-dilatation balloon (including, but not only restricted to laser, cutting balloon, directional coronary atherectomy, rotational atherectomy etc...)
  18. Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Enrollment
500 participants (estimated)

Interventions

  • DevicePantera Lux Drug Eluting Balloon

    All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.

06

What researchers measure

Primary outcomes

  1. Target Lesion Failure (TLF) at 12 months.

    TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), urgent coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).

    Time frame: 12 months

Secondary outcomes

  1. Target Lesion Failure

    Time frame: 1 and 6 months

  2. Bleeding rate according to BARC definition

    Time frame: 1, 6 and 12 months

  3. Clinically driven target vessel revascularization

    Time frame: 1, 6 and 12 months

  4. MACCE

    Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft

    Time frame: 1, 6 and 12 months

  5. All deaths

    Time frame: 1, 6 and 12 months

  6. Myocardial Infarction (MI) (Q wave and non Q wave)

    Time frame: 1, 6 and 12 months

  7. Definite incidence of stent thrombosis

    Time frame: 1, 6 and 12 months

  8. Clinically driven target lesion revascularization

    Time frame: 1, 6 and 12 months

  9. Target lesion failure for patients >/= 80 years

    Time frame: 1, 6 and 12 months

  10. Bleeding rate according to BARC definition for patients >/= 80 years

    Time frame: 1, 6 and 12 months

  11. Target lesion failure for kidney failure patients (clearance < 30 ml/ min)

    Time frame: 1, 6 and 12 months

  12. Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)

    Time frame: 1, 6 and 12 months

07

Study locations

1 site
  • Chu Toulouse
    Toulouse, France
08

References and documents

Publications

  • Roncalli J, Godin M, Boughalem K, Shayne J, Piot C, Huret B, Belle L, Cayla G, Faurie B, Amor M, Karsenty B, Leclercq F. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J Invasive Cardiol. 2019 Apr;31(4):94-100. PubMed 30927531 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01930903
Lead sponsor
Biotronik France
Collaborators
MedPass International
Responsible party
Sponsor
First posted
Aug 29, 2013
Start date
Sep 2013
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Apr 30, 2015

Study contacts

Jérôme Roncalli, Prof
principal investigator · CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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