SUPRAFLEX CRUZ STENT - The FIRE Trial · 2019. 7. 1. · (STEMI, NSTEMI, UAP, SAP) Any type of...

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