Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07038408

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Drug Coated Balloon Acute Coronary Syndrome Acute Coronary Syndrome (ACS) Bioresorbable Scaffold Cardiovascular Diseases Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention (PCI) Vascular Diseases

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Põhja-Eesti Regionaalhaigla

Tallinn, 13419, Estonia

Location status: Recruiting

Location contact

Peep Laanmets

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angioplasty with DCB (bail-out BRS)

Procedure

Angioplasty starts with lesion preparation in both arms with a PTCA balloon catheter.

The lesion is treated with the Mozec SEB through femoral or brachial artery. The DCB should be delivered to the target lesion within 120 seconds of insertion into the guide catheter. Under fluoroscopic visualization, the DCB is inflated at least 30 seconds (single inflation). If the results are insufficient, multiple inflation is permitted. If despite appropriate delivery and inflation of the DCB, the results remain insufficient bail-out BRS should be performed.

Bail-out BRS is performed through femoral or brachial artery. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, Optical Coherence Tomography (OCT) is performed, if available.

Other names: DCB arm with bail-out BRS

Angioplasty with BRS

Procedure

Bail-out BRS is performed through femoral or brachial artery. BRS implantation is guided by OCT, if available. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, OCT is performed, if available.

Other names: BRS arm

Primary outcomes

  1. Target-vessel Failure (TVF)

    Time frame: From enrollment to the end of treatment at 12 months

    Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization

Secondary outcomes

  1. Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years.

    Time frame: From enrollment to the end of treatment at every year from 2 years until 5 years follow-up

    Target vessel failiure is defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization

  2. Target-Lesion Failure (TLF)

    Time frame: From enrollment to the end of treatment every year until end of 5 years

    Target Lesion Failure is is defined as the composite of cardiac death, target vessel-related myocardial infarction (Q wave and non-Q wave) and ischemia-driven target lesion revascularization

  3. (Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings

    Time frame: From enrollment to the end of treatment every year until end of 5 years

    BARC definitions Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, type 4, or type 5 but does meet at least one of the following criteria: requiring nonsurgical, medical intervention by a health care professional; leading to hospitalization or increased level of care; or prompting evaluation.

    Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL* ; any transfusion with overt bleeding.

    Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL ; cardiac tamponade; bleeding requiring surgical intervention for control ; bleeding requiring intravenous vasoactive agens.

    Type 3c: intracranial hemorrhage

  4. Net Adverse Clinical Event (NACE)

    Time frame: From enrollment to the end of treatment every year until end of 5 years

    NACE defined as all-cause death, myocardial infarction, all-stroke, ischemia driven TVR or BARC 3 or 5 bleeding

Other outcomes

  1. Acute Gain

    Time frame: From enrollment to the end of treatment at 13 months

    Acute gain (in-lesion and in-segment)

  2. Late Loss

    Time frame: From enrollment to the end of treatment at 13 months

    Late loss (in-lesion and in-segment)

  3. In-segment Late Lumen Loss (LLL)

    Time frame: From enrollment to the end of treatment at 13 months

    In segment LLL in vessels with RVD < 3.0 mm and ≥ 3.0 mm

Study contacts

Contact information is provided by the study sponsor or research team.

CERC France

CONTACT

[email protected]

DAVIDE CAPODANNO, Professor

CONTACT

[email protected]

+39-3393238566

Sponsors and collaborators

Lead sponsor

Ceric Sàrl

Industry

Registry information

Official study title

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.

Acronym: LNB

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Jun 26, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.