Clinical trial NCT01930903: PaneLux PTCA : Proposing an Alternative Treatment to patiEnts for Whom DES Implantation is Not Indicated, Thanks to Pantera LUX Drug Eluting Balloon
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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
High Bleeding Risk Patients
Keywords: PRO-Kinetic Energy BMS + Pantera Lux DEB combination
Lead sponsor: Biotronik France
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2013-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Target Lesion Failure (TLF) at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 1 and 6 months
measure: Bleeding rate according to BARC definition
timeFrame: 1, 6 and 12 months
measure: Clinically driven target vessel revascularization
timeFrame: 1, 6 and 12 months
measure: MACCE
timeFrame: 1, 6 and 12 months
measure: All deaths
timeFrame: 1, 6 and 12 months
measure: Myocardial Infarction (MI) (Q wave and non Q wave)
timeFrame: 1, 6 and 12 months
measure: Definite incidence of stent thrombosis
timeFrame: 1, 6 and 12 months
measure: Clinically driven target lesion revascularization
timeFrame: 1, 6 and 12 months
measure: Target lesion failure for patients >/= 80 years
timeFrame: 1, 6 and 12 months
measure: Bleeding rate according to BARC definition for patients >/= 80 years
timeFrame: 1, 6 and 12 months
measure: Target lesion failure for kidney failure patients (clearance < 30 ml/ min)
timeFrame: 1, 6 and 12 months
measure: Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)
timeFrame: 1, 6 and 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9
name: Jérôme Roncalli, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.25270/jic/18.00272.