The objective of this study is to evaluate the safety and effectiveness of Genoss® SCB by comparing in-segment late lumen loss (LLL) to the control group (SeQuent® Please NEO) at 6 months in patients with coronary stent-in-stent restenosis (ISR) with a reference vessel diameter of 2.0-4.0 mm.
This pivotal study is a randomized controlled trial to compare with the control group (SeQuent® Please NEO), and will recruit 94 patients with in-stent restenosis (ISR) from 9 institutions. The test group (Genoss® SCB) and the control group (SeQuent® Please NEO) will be randomly assigned 1:1, and all patients will be followed up at 1, 6, and 12 months after the procedure. The primary endpoint is to evaluate in-segment late lumen loss by quantitative coronary angiography (QCA) by an independent assessor at 6 months after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
Drug Coated Balloon
Drug Coated Balloon
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
In-segment late lumen loss after procedure
In-segment refers to a portion including within 5 mm of each of the distal and proximal portions at the boundary of the inserted stent. Therefore, in-segment late lumen loss (LLL) is defined as the difference (mm) in the minimum lumen diameter (MLD) within the segment at 6 months from baseline.
Time frame: at 6 months after procedure
In-stent late lumen loss after procedure
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.
Time frame: at 6 months after procedure
Target Lesion Failure (TLF), %
Target lesion failure is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI), and target lesion revascularization (TLR).
Time frame: at 1 month, 6 months, and 12 months after procedure
Patient-oriented composite endpoint (POCE), %
POCE is defined as a composite of all-cause death, any myocardial infarction (MI), any revasularization or stroke.
Time frame: at 1 month, 6 months, and 12 months after procedure
Device success rate, %
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.
Time frame: Immediately after the procedure
Procedural success rate, %
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: up to 24 hours
Binary restenosis rate, %
defined as a in-segment diameter stenosis ≥ 50% at angiographic follow-up
Time frame: at 6 months after procdure
Cardiac Death, %
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)
Time frame: at 1 month, 6 months, and 12 months after procedure
All-cause death, %
Incidence rate of all-cause death including cardiac death.
Time frame: at 1 month, 6 months, 12 months after procedure
Target vessel myocardial infarction (TV-MI), %
Incidence rate of target vessel myocardial infarction
Time frame: at 1 month, 6 months, and 12 months after procedure
Myocardial infarction (MI), %
Incidence rate of all myocardial infarction
Time frame: at 1 month, 6 months, and 12 months after procedure
Ischemia-driven target lesion revascularization (ID-TLR), %
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.
Time frame: at 1 month, 6 months, and 12 months after procedure
Ischemia-driven target vessel revascularization (ID-TVR), %
Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.
Time frame: at 1 month, 6 months, and 12 months after procedure
Revascularization, %
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.
Time frame: at 1 month, 6 months, and 12 months after procedure
Stent thrombosis
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
Time frame: at 1 month, 6 months, and 12 months after procedure
Stroke, %
Neuro-ARC definitions (according to ARC-2 criteria)
Time frame: at 1 month, 6 months, and 12 months after procedure
Major bleeding BARC type III to V, %
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.
Time frame: at 1 month, 6 months, and 12 months after procedure
Abrupt closure/ Sub abrupt closure, %
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).
Time frame: at 1 months after procedure