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Coronary Artery DiseasePaneLux PTCANCT01930903

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

A study testing Pantera Lux Drug Eluting Balloon in people with Coronary Artery Disease and High Bleeding Risk Patients, run by Biotronik France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pantera Lux Drug Eluting Balloon
Type of treatment
Medical device
How many people
500 participants
Where
1 siteFrance
Study dates
Sep 2013to Dec 2015
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.
  • Patient affiliated to social security
  • Patient acceptable candidate who accept to be contacted at different terms of clinical follow up (1, 6 and 12 months)
  • 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
  • Subject eligible for Dual Anti Platelet Therapy (DAPT) of acetyl salicylic acid and clopidogrel for at least 3 weeks
Show all 10Show fewer
  • De Novo coronary lesions: >/= 50% - <100%
  • Subject, vessels and target lesion eligible for angioplasty with PRO-Kinetic Energy stent implantation and final post-dilatation with Pantera Lux drug eluting balloon.
  • Target lesion length </= 26 mm , visual estimation or by Quantitative Coronary Angiography (QCA)
  • Reference diameters targeted vessels >/=2.5mm and </= 4.0 mm (visual estimation or QCA)

Who cannot join

  • Pregnant or breast feeding females or females who intend to become pregnant during the time of the study
  • Subject with a life expectancy less than 1 year
  • Vulnerable subject, protected by law, unable to give his/her consent
  • Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures of that study
  • Subject unable to be contacted for the clinical follow up at 1, 6 and 12 months
  • Subject under chronical oral anti-coagulant treatment (optionnal indication)
Show all 18Show fewer
  • 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
  • In stent restenotic lesion
  • Target lesion on vessels with nominal diameter < 2.5 mm
  • Target lesion is located in or supplied by an arterial or venous bypass graft
  • Chronical Total occlusion (CTO)
  • Angioplasty indication for STEMI
  • Patient with signs of cardiogenic shock
  • Angioplasty antecedent with stent implantation (before 12 months for DES, before 6 months for BMS)
  • "Staged procedure" > 8 days after the initial angioplasty
  • Documented left ventricular ejection fraction (LVEF) </= 30%
  • 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…)
  • Known allergies to acetylsalicylic acid, active agent such Paclitaxel, Expicients like BHTC (Butiriltri-n-hexyl citrate), CoCr, Silicon Carbide.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu Toulouse

    Toulouse

Other trials in France

About this study

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

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.

Being tested
Pantera Lux Drug Eluting Balloon
Keywords
PRO-Kinetic Energy BMS + Pantera Lux DEB combination
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Pantera Lux Drug Eluting BalloonDevice

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

What is being measured

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

  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).

    Measured: 12 months

Secondary outcomes (12)

  1. Target Lesion Failure

    Measured: 1 and 6 months

  2. Bleeding rate according to BARC definition

    Measured: 1, 6 and 12 months

  3. Clinically driven target vessel revascularization

    Measured: 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

    Measured: 1, 6 and 12 months

  5. All deaths

    Measured: 1, 6 and 12 months

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

    Measured: 1, 6 and 12 months

  7. Definite incidence of stent thrombosis

    Measured: 1, 6 and 12 months

  8. Clinically driven target lesion revascularization

    Measured: 1, 6 and 12 months

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

    Measured: 1, 6 and 12 months

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

    Measured: 1, 6 and 12 months

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

    Measured: 1, 6 and 12 months

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

    Measured: 1, 6 and 12 months

Timeline

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

  1. First posted29 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2015 (estimated)
  4. Study completionDec 2015 (estimated)

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
Non-randomised
Intervention model
Single group
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01930903
Sponsor's protocol ID
201202
Acronym
PaneLux PTCA
Status last verified
Feb 2014
First submitted
26 Aug 2013
Last updated
30 Apr 2015
Results posted
No
Data monitoring committee
No

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. doi: 10.25270/jic/18.00272.

    PubMed 30927531

Questions about this trial

What is this clinical trial studying?

A study testing Pantera Lux Drug Eluting Balloon in people with Coronary Artery Disease and High Bleeding Risk Patients, run by Biotronik France at 1 site in France.

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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Results are not available in the source record.

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?

Target Lesion Failure (TLF) at 12 months. (time frame: 12 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 NCT01930903, which also lists 1 linked publication.

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 30 Apr 2015.

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