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

Primary Purpose

Coronary Artery Disease, High Bleeding Risk Patients

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pantera Lux Drug Eluting Balloon
Sponsored by
Biotronik France
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring PRO-Kinetic Energy BMS + Pantera Lux DEB combination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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.

Sites / Locations

  • Chu Toulouse

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Target Lesion Failure
Bleeding rate according to BARC definition
Clinically driven target vessel revascularization
MACCE
Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft
All deaths
Myocardial Infarction (MI) (Q wave and non Q wave)
Definite incidence of stent thrombosis
Clinically driven target lesion revascularization
Target lesion failure for patients >/= 80 years
Bleeding rate according to BARC definition for patients >/= 80 years
Target lesion failure for kidney failure patients (clearance < 30 ml/ min)
Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)

Full Information

First Posted
August 26, 2013
Last Updated
April 29, 2015
Sponsor
Biotronik France
Collaborators
MedPass International
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1. Study Identification

Unique Protocol Identification Number
NCT01930903
Brief Title
PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
Acronym
PaneLux PTCA
Official Title
Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik France
Collaborators
MedPass International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, High Bleeding Risk Patients
Keywords
PRO-Kinetic Energy BMS + Pantera Lux DEB combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pantera Lux Drug Eluting Balloon
Intervention Description
All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.
Primary Outcome Measure Information:
Title
Target Lesion Failure (TLF) at 12 months.
Description
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 Outcome Measure Information:
Title
Target Lesion Failure
Time Frame
1 and 6 months
Title
Bleeding rate according to BARC definition
Time Frame
1, 6 and 12 months
Title
Clinically driven target vessel revascularization
Time Frame
1, 6 and 12 months
Title
MACCE
Description
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
Title
All deaths
Time Frame
1, 6 and 12 months
Title
Myocardial Infarction (MI) (Q wave and non Q wave)
Time Frame
1, 6 and 12 months
Title
Definite incidence of stent thrombosis
Time Frame
1, 6 and 12 months
Title
Clinically driven target lesion revascularization
Time Frame
1, 6 and 12 months
Title
Target lesion failure for patients >/= 80 years
Time Frame
1, 6 and 12 months
Title
Bleeding rate according to BARC definition for patients >/= 80 years
Time Frame
1, 6 and 12 months
Title
Target lesion failure for kidney failure patients (clearance < 30 ml/ min)
Time Frame
1, 6 and 12 months
Title
Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)
Time Frame
1, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) Exclusion Criteria: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme Roncalli, Prof
Organizational Affiliation
CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30927531
Citation
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.
Results Reference
derived

Learn more about this trial

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

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