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

Ceric Sàrl

Status: Begins enrollment in 1 month

Conditions: Drug Coated Balloon; Bioresorbable Scaffold; Acute Coronary Syndrome (ACS); Percutaneous Coronary Intervention (PCI)

Treatments: Procedure: Angioplasty with BRS; Procedure: Angioplasty with DCB (bail-out BRS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07038408

Leave Nothing Behind

Details and patient eligibility

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

Full 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.

Enrollment: 2,256 estimated patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,256 participants in 2 patient groups

DCB treatment (Mozec SEB)

Experimental group

Description:

Mozec SEB is used during the angioplasty (V2) for patients randomized in the DCB arm with bail-out BRS. If the operator considers the results as insufficient, the MeRes100 is also used in the patient.

Treatment:

Procedure: Angioplasty with DCB (bail-out BRS)

BRS treatment (MeRes100)

Active Comparator group

Description:

MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm.

Treatment:

Procedure: Angioplasty with DCB (bail-out BRS)

Procedure: Angioplasty with BRS