The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \[NSTEMI\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are:
DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy?
Participants will be followed at:
1. st FU visit - 1 month (in hospital) 2. nd FU visit - 6 months (telephone) 3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint 4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy 5. th FU visit - 730 days±30 days (telephone call) - 2Y 6. th FU visit - 1095 days±30 days (telephone call) - 3Y 7. th FU visit - 1460 days±30 days (telephone call) - 4Y 8. th FU visit- 1825 days±30 days (telephone call) - 5Y
Patients aged ≥ 18 years ≤ 68 years
Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm
Maximum of 3 target lesions
Maximal cumulative lesion length of all treated lesions 80 mm
ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours
Severe calcified lesions
Bifurcations lesions with planned 2 device strategy
Left-Main (LM) disease ≥ 50% diameter stenosis
Parallel
Angioplasty with DCB (bail-out BRS)
Procedure/SurgeryAngioplasty starts with lesion preparation in both arms with a PTCA balloon catheter. The lesion is treated with the Mozec SEB through femoral or brachial artery. The DCB should be delivered to the target lesion within 120 seconds of insertion into the guide catheter. Under fluoroscopic visualization, the DCB is inflated at least 30 seconds (single inflation). If the results are insufficient, multiple inflation is permitted. If despite appropriate delivery and inflation of the DCB, the results remain insufficient bail-out BRS should be performed. Bail-out BRS is performed through femoral or brachial artery. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, Optical Coherence Tomography (OCT) is performed, if available.
Angioplasty with BRS
Procedure/SurgeryBail-out BRS is performed through femoral or brachial artery. BRS implantation is guided by OCT, if available. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, OCT is performed, if available.
Target-vessel Failure (TVF)
Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization
Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years.
Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization
Target-Lesion Failure (TLF)
Target Lesion Failure is is defined as the composite of cardiac death, target vessel-related myocardial infarction (Q wave and non-Q wave) and ischemia-driven target lesion revascularization
(Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings
BARC definitions Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, type 4, or type 5 but does meet at least one of the following criteria: requiring nonsurgical, medical intervention by a health care professional; leading to hospitalization or increased level of care; or prompting evaluation. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL\* ; any transfusion with overt bleeding. Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL ; cardiac tamponade; bleeding requiring surgical intervention for control ; bleeding requiring intravenous vasoactive agens. Type 3c: intracranial hemorrhage
Net Adverse Clinical Event (NACE)
NACE defined as all-cause death, myocardial infarction, all-stroke, ischemia driven TVR or BARC 3 or 5 bleeding
Acute Gain
Acute gain (in-lesion and in-segment)
Late Loss
Late loss (in-lesion and in-segment)
In-segment Late Lumen Loss (LLL)
In segment LLL in vessels with RVD \< 3.0 mm and ≥ 3.0 mm
