Actively Recruiting

Phase Not Applicable
Age: 18Years - 68Years
All Genders
NCT07038408

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

Age: 18Years - 68Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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