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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07038408
• Lead Sponsor: Ceric Sàrl

Brief 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

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-08-10
• Primary Completion: 2027-02-20
• Study Completion: 2032-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target-vessel Failure (TVF)	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 Outcome Measures

Name	Time	Method
Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years.	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
Target-Lesion Failure (TLF)	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
(Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings	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
Net Adverse Clinical Event (NACE)	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