An interventional study of Pantera Lux Drug Eluting Balloon in Coronary Artery Disease and High Bleeding Risk Patients, sponsored by Biotronik France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by Biotronik France · Not applicable, Interventional, and Treatment
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 500 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Biotronik France is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.
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).
Time frame: 12 months
Target Lesion Failure
Time frame: 1 and 6 months
Bleeding rate according to BARC definition
Time frame: 1, 6 and 12 months
Clinically driven target vessel revascularization
Time frame: 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
Time frame: 1, 6 and 12 months
All deaths
Time frame: 1, 6 and 12 months
Myocardial Infarction (MI) (Q wave and non Q wave)
Time frame: 1, 6 and 12 months
Definite incidence of stent thrombosis
Time frame: 1, 6 and 12 months
Clinically driven target lesion revascularization
Time frame: 1, 6 and 12 months
Target lesion failure for patients >/= 80 years
Time frame: 1, 6 and 12 months
Bleeding rate according to BARC definition for patients >/= 80 years
Time frame: 1, 6 and 12 months
Target lesion failure for kidney failure patients (clearance < 30 ml/ min)
Time frame: 1, 6 and 12 months
Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)
Time frame: 1, 6 and 12 months
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Biotronik France