Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone

Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.

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

The Leave Nothing Behind Study is an is an investigator-initiated trial. The Primary efficacy endpoint is target-vessel failure (TVF), defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization (TVR) at 12 months.

Co-primary efficacy endpoint (angiographic substudy) is the in-segment net gain at 13 months.

Investigators aim to enroll 2256 patients in the main study and 196 patients in the angiographic substudy.

Inclusion Criteria:

• 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
• Signed informed consent for participation in the study

Exclusion Criteria:

• 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
• More than 3 target lesions
• Renal insufficiency with Glomerular Filtration Rate (GFR) < 45 ml/min
• Life expectancy less than 1 year
• Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors
• Incapable of providing written informed consent
• Pregnant or breastfeeding women
• Under judicial protection, tutorship, or curatorship
• Participation in another trial