This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.
Study Type
OBSERVATIONAL
Enrollment
1,200
Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care
Centre Hospitalier Haguenau
Haguenau, France
Hôpital Privé Jacques Cartier
Massy, France
CHRU de Montpellier
Montpellier, France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France
Clinique Saint Hilaire
Rouen, France
CHU de Toulouse - Rangueil
Toulouse, France
Kerckhoff Heart Center
Bad Nauheim, Germany
Heart and Diabetes Center Nordrhine Westfalia
Bad Oeynhausen, Germany
Segeberg Kliniken
Bad Segeberg, Germany
Charité Campus Mitte
Berlin, Germany
...and 16 more locations
Device Oriented Composite Endpoint (DOCE)
DOCE is a composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically-driven target lesion revascularization (TLR)
Time frame: 12 months
All death, cardiovascular death and non-cardiovascular death
Time frame: 6 months and 12 months
All myocardial infarction (MI)
Time frame: 6 months and 12 months
Target vessel MI and MI not clearly attributable to non-target vessel
Time frame: 6 months and 12 months
Clinically indicated target lesion revascularization (TLR)
Time frame: 6 months and 12 months
All target lesion revascularization (TLR)
Clinically and non-clinically indicated target lesion revascularization (TLR)
Time frame: 6 months and 12 months
All target vessel revascularization (TVR)
Clinically and non-clinically indicated target vessel revascularization (TVR)
Time frame: 6 months and 12 months
All revascularization
Any revascularization, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR
Time frame: 6 months and 12 months
Stent thrombosis (ARC2)
Time frame: 6 months and 12 months
Device success
Defined as deployment of the stents without system failure or device-related complication
Time frame: Up to 1 Day
Lesion success
Defined as the attainment of \< 50% residual stenosis of the target lesions post-PCI
Time frame: Up to 1 Day
Procedure success
Defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay
Time frame: Up to 7 Days
Major bleeding (BARC 3 to 5) in the HBR population
Time frame: 6 months and 12 months
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