Overview
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:
- st FU visit - 1 month (in hospital)
- nd FU visit - 6 months (telephone)
- rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
- th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
- th FU visit - 730 days±30 days (telephone call) - 2Y
- th FU visit - 1095 days±30 days (telephone call) - 3Y
- th FU visit - 1460 days±30 days (telephone call) - 4Y
- th FU visit- 1825 days±30 days (telephone call) - 5Y
Description
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.
Eligibility
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
