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SUPRAFLEX CRUZ STENT
Main characteristics and studies
Stent details
Stent details
LDZ = Long Dual Z link
Platform
Platform – LDZ link
Deliverability
Strut thickness
Main benefits related to lower strut thickness
Cell opening
Post-Dilatation
Polmer and drug release
Clinical studies
General details of the study
▪ Hypothesis
▪ Non-inferiority of device-oriented endpoint (DOCE) – a composite of cardiac
death, target vessel myocardial infarction, and clinically-indicated target
lesion revascularization – in the Supraflex arm compared with the Xience
arm at 12 months post-procedure.
▪ Sample size calculation
▪ Expected DOCE rate of Xience at 12 months: 8.3% (Resolute All-comers
(Xience arm)*
▪ Non-inferiority margin of 4.0%
▪ One-sided type I error of 0.05
▪ 85% power to detect non-inferiority
▪ Assume lost to follow-up of 3%
• A total of 1435 subjects were to be randomized.
Non inferiority
Baseline Characteristics
Procedural details
Lesion details
Device success
Device success
Primary endpoint
Non inferiority
Original Hypothesis
Post-Hoc Hypothesis
Cardiac death
Cardiac death
Target vessel MI
Stent thrombosis
Clinically indicated TLR
Per protocol analysis
Future clinical studies
Future clinical studies