The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,398
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention
Research Center Corbeil
Corbeil, France
Research Center Nimes
Nîmes, France
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE)
DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization.
Time frame: 12 months postprocedure
POCE
POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization
Time frame: At 12 months
MACE
MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR)
Time frame: At 12 months
Target Vessel Failure (TVF)
Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR
Time frame: At 12 months
All-cause Death
All-cause death
Time frame: At 12 months
Myocardial Infarction
Any Myocardial infarction
Time frame: At 12 months
Any Revascularization
Any revascularization
Time frame: At 12 months
Stent Thrombosis
Definite or probably stent thrombosis according to ARC
Time frame: At 12 months
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Research Center Poitiers
Poitiers, France
Research Center Jena
Jena, Germany
Research Center Leipzig
Leipzig, Germany
Research Center Munster
Münster, Germany
Research Center Ulm
Ulm, Germany
Research Center Wiesbaden
Wiesbaden, Germany
Research Center Amersfoort
Amersfoort, Netherlands
Research Center Amsterdam
Amsterdam, Netherlands
...and 10 more locations