Actively Recruiting
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
Led by Ceric Sàrl · Updated on 2026-04-30
2256
Participants Needed
1
Research Sites
305 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 68 years
- Have single or multivessel disease with low to moderate complexity new coronary artery lesions up to 30 mm in length and vessel diameter between 2.75 and 4.0 mm
- Have a maximum of 3 target lesions
- Total length of all treated lesions must not exceed 80 mm
- Have signed informed consent to participate in the study
You will not qualify if you...
- Treated for ST-segment Elevation Myocardial Infarction (STEMI) at the time of or within 48 hours before the study
- Have severely calcified lesions
- Have bifurcation lesions planned for two-device treatment
- Have Left-Main disease with 50% or greater diameter narrowing
- Have more than 3 target lesions
- Have kidney failure with Glomerular Filtration Rate less than 45 ml/min
- Have a life expectancy less than one year
- Are allergic or sensitive to aspirin or P2Y12 receptor inhibitors
- Are unable to provide written informed consent
- Are pregnant or breastfeeding
- Are under judicial protection, guardianship, or curatorship
- Are participating in another clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Põhja-Eesti Regionaalhaigla
Tallinn, Estonia, 13419
Actively Recruiting
Research Team
D
DAVIDE CAPODANNO, Professor
CONTACT
C
CERC France
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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