The SELUTION DeNovo Study

Subjects must meet all the following criteria to participate in the trial:

• Subject age is ≥ 18 years (or 21 according to countries legal age)

• Female subjects of childbearing potential have a negative pregnancy test ≤7 daysbefore the procedure or are using a contraceptive device or drug.

• Documented angina and/or positive functional testing or unstable angina orstabilized NSTEMI presentation.

• Life expectancy >1 year

• Written informed consent by the subject or her/his legally authorized representativefor participation in the study

• One or more native target vessel (LAD, LCX or RCA) is considered to requireintervention and is suitable for treatment of all lesions with either DEB +provisional stenting or with DES and is identified as such.

• The number of trial target lesions is not limited, but in the operator's opinion, ifthe subject is randomized to the DEB arm, the likelihood of the subject requiringprovisional stenting of any of the identified trial target lesions is < 30%, and ifrandomized to the systematic DES arm, all lesions are considered amenable tostenting.

• All target lesions: diameter between 2.0 and 5 mm, and diameter stenosis >50% and <100% with distal flow at least TIMI 2

Exclusion Criteria:

Age < 18 years (or 21 according to countries legal age)

• Subject is pregnant or breast-feeding

• Definite or suspected clinically active covid-19 infection

• Subject is under judicial protection, tutorship or curatorship (for France only)

• Subject is unable to fully comply with the study protocol

• Contraindications to dual antiplatelet therapy, sirolimus or its analogues

• Presentation with STEMI

• Presentation with NSTEMI and ongoing chest pain or hemodynamic instability

• Presentation with Killip III (pulmonary oedema) or IV (cardiogenic shock)

• Chronic NYHA class III or IV heart failure prior to index PCI

• Known LVEF < 30% prior to index PCI

• Previous PCI of a trial target vessel at any time

• Previous PCI of a non-trial target vessel within 30 days

• Trial target lesion located in the left main or any arterial or venous graft

• Trial target lesion is chronic total occlusion (CTO) or in-stent restenosis (ISR)

• Subject considered not able to tolerate at least 30 seconds of coronary occlusionfor each trial target lesion

• RVD of trial target lesion > 5mm

• Planned major surgery within one month following the procedure

• Currently participating in another investigational drug or device study that has notcompleted primary endpoint follow-up