The primary objectives of this trial are: In patients at high-risk for restenosis, * To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year * To assess superiority of the BRS to the EES in TLF between 3 and 7 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,670
non-inferiority of the everolimus-eluting bioresorbable scaffold (Absorb) to the everolimus eluting cobalt chromium metallic stent (Xience) in target lesion failure (TLF)
Composite of: * Cardiac death * Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI) * Clinically Indicated Target lesion revascularization
Time frame: 1 year
superiority of the Absorb to the Xience in TLF between 3 and 7 years
Time frame: 5 years
Superiority of the Absorb to the Xience in TLF at 7 years
Time frame: 7 years
Superiority of the Absorb to the XIence in cumulative angina rate at 1 year
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardiovascular Center Aalst OLV
Aalst, Belgium
CHR Citadelle
Leuven, Belgium
UZ Leuven
Leuven, Belgium
University Hospital Brno
Brno, Czechia
Cardiocentre, University Hospital Kralovske
Prague, Czechia
Central Military Hospital
Prague, Czechia
Clinique Rhône Durance
Avignon, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital Privé Jacques Cartier
Massy, France
Clinique Saint-Hilaire
Rouen, France
...and 34 more locations