Coronary Artery Disease, High Bleeding Risk Patients
Conditions
Keywords
PRO-Kinetic Energy BMS + Pantera Lux DEB combination
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.
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.
Sponsors
MedPass International
Biotronik France
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) at 12 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Target lesion failure for patients >/= 80 years | 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 | — |
| Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min) | 1, 6 and 12 months | — |
| MACCE | 1, 6 and 12 months | Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft |
Countries
France
Outcome results
None listed