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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; High Bleeding Risk Patients
• Intervention / Treatment: Device: Pantera Lux Drug Eluting Balloon

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure		1 and 6 months
Bleeding rate according to BARC definition		1, 6 and 12 months
Clinically driven target vessel revascularization		1, 6 and 12 months
MACCE	Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft	1, 6 and 12 months
All deaths		1, 6 and 12 months
Myocardial Infarction (MI) (Q wave and non Q wave)		1, 6 and 12 months
Definite incidence of stent thrombosis		1, 6 and 12 months
Clinically driven target lesion revascularization		1, 6 and 12 months
Target lesion failure for patients >/= 80 years		1, 6 and 12 months
Bleeding rate according to BARC definition for patients >/= 80 years		1, 6 and 12 months
Target lesion failure for kidney failure patients (clearance < 30 ml/ min)		1, 6 and 12 months
Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)		1, 6 and 12 months

Collaborators and Investigators

• Sponsor: Biotronik France
• Collaborators: MedPass International
• Investigators: Principal Investigator: Jérôme Roncalli, Prof, CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: PRO-Kinetic Energy BMS + Pantera Lux DEB combination
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 201202