The Safety and Efficacy for In-segment Late Lumen Loss of the 'Genoss® SCB' Versus 'SeQuent® Please NEO' in Patients With Coronary ISR

In-stent refers to a portion between each of the distal and proximal portions. Therefore, in-stent late lumen loss (LLL) is defined as the difference (mm) in the minimum lumen diameter (MLD) within the segment at 6 months from baseline. This is assessed by an independent evaluator using quantitative coronary angiography analysis (QCA) imaging.

Target lesion failure is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), and target lesion revascularization (TLR).

POCE is defined as a composite of all-cause death, any myocardial infarction (MI), any revasularization or stroke.

Device success rate is defined as successful delivery of the device to the target lesion during the procedure, normal inflation, deflation, and catheter withdrawal of the without balloon rupture.

The definition of procedural success includes the of device success, freedom adverse events in-hospital [cardiovascular death, target lesion revascularization, peri-procedural myocardial infarction, any stroke, and BARC 3-5 bleeding], and freedom from bail-out stenting.

defined as a in-segment diameter stenosis ≥ 50% at angiographic follow-up

Death caused by acute MI, Sudden cardiac, including unwitnessed, death, Death resulting from heart failure, Death caused by stroke, Death caused by cardiovascular procedures, Death resulting from cardiovascular haemorrhage (haemorrhage deriving from cardiac and/or vascular disease/injuries)

Incidence rate of all-cause death including cardiac death.

Incidence rate of target vessel myocardial infarction

Incidence rate of all myocardial infarction

Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.

Revascularizations are defined according to the vessel/lesion treated and are identified as target or non-target, based on the initial site of the treatment.

Stent thrombosis will be assessed and classified according to the definitions established by the Academic Research Consortium-2 (ARC-2).

Stent thrombus is classified based on how the diagnosis is confirmed. These classifications include definite, and probable stent thrombosis.

Definite stent thrombosis Requires confirmation of stent thrombosis on angiography.

Probable stent thrombosis Consider if there is active ischemia on electrocardiogram (EKG) or stress in the distribution of prior stent and absence of significant coronary lesion on angiography.

Timing may be divided between acute, subacute, early, and late.

When classified as early, or late:

Early stent thrombosis occurs within one month of initial placement. Late stent thrombosis occurs between 1 and 12 months of initial placement.

Early stent thrombosis is divided between acute or subacute:

Acute thrombosis occurs within 24 hours of initial placement. Subacute thrombosis occurs between 24 hours to one month of initial place

Neuro-ARC definitions (according to ARC-2 criteria)

Major bleeding according to the Bleeding Academic Research Consortium (BARC) scale includes BARC types 3 to 5. Type 3 bleeding encompasses significant bleeding, including overt bleeding with a hemoglobin drop, intracranial hemorrhage, and bleeding requiring surgery or vasoactive agents. Type 4 refers to bleeding related to coronary artery bypass grafting (CABG). Type 5 bleeding is fatal, either probable or definite.

BARC Type 3: Significant Bleeding 3a: Overt bleeding plus a hemoglobin drop of 3-5 g/dL. 3b: Overt bleeding plus a hemoglobin drop of 3-5 g/dL, cardiac tamponade, surgical intervention required, or intravenous vasoactive agents used.

3c: Intracranial hemorrhage.

BARC Type 5: Fatal Bleeding 5a: Probable fatal bleeding, no definitive cause of death but clinically suspected.

5b: Definite fatal bleeding, confirmed by imaging or autopsy.

① Abrupt closure: Defined as a newly developed, significant reduction in blood flow within the target vessel (TIMI grade 0 or 1) that persists and requires an unplanned rescue strategy (including emergency surgery). This must be associated with mechanical dissection of the treated or manipulated vessel, coronary thrombosis, or severe spasm.

② Sub-abrupt closure: Defined as abrupt closure occurring after the index procedure (after the patient has left the procedure room) but before Visit 3 (4 weeks post-procedure).