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

Summary

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

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

Conditions5

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