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

Official 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.

Overview

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.

Interventions

• Procedure Angioplasty with DCB (bail-out BRS)
  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
• Procedure Angioplasty with BRS
  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.

Primary outcome measures

• Target-vessel Failure (TVF) [Time frame: From enrollment to the end of treatment at 12 months]

Secondary outcome measures (4)

• 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-Lesion Failure (TLF) [Time frame: From enrollment to the end of treatment every year until end of 5 years]
• (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]
• Net Adverse Clinical Event (NACE) [Time frame: From enrollment to the end of treatment every year until end of 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Estonia · 1 center

• Põhja-Eesti Regionaalhaigla — Tallinn

Publications

• Verma PK, Sroa S, Koushal P. A real-world experience with a thin-strut bioresorbable vascular scaffold system: a single-centre study. AsiaIntervention. 2025 Mar 20;11(1):26-34. doi: 10.4244/AIJ-D-24-00033. eCollection 2025 Mar. PMID 40114731
• Abizaid A, Kedev S, Ali RBM, Santoso T, Cequier A, van Geuns RVG, Chevalier B, Hellig F, Costa R, Onuma Y, Costa JR Jr, Serruys P, Bangalore S. Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1102-1110. doi: 10.1002/ccd.29396. Epub 2020 Dec 2. PMID 33269506
• Seth A, Onuma Y, Chandra P, Bahl VK, Manjunath CN, Mahajan AU, Kumar V, Goel PK, Wander GS, Kaul U, Ajit Kumar VK, Abizaid A, Serruys PW. Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial. EuroIntervention. 2019 Sep 20;15(7):607-614. doi: 10.4244/EIJ-D-19-00324. PMID 31147308
• Premchand Jain RK, Parikh K, Sethuraman S, Sharma K, Roy S, Vithala SR, Gollamandala KR, Packirisamy G, Mantravadi SS, Roleder T. Safety and Performance of the MOZEC Sirolimus-Eluting Coronary Balloon in the Treatment of Stenotic Coronary Artery Lesions: A Real-World, Multicenter, Post-Marketing Surveillance Study. Cardiol Res. 2025 Apr;16(2):130-139. doi: 10.14740/cr2026. Epub 2025 Feb 28. PMID 40051667
• Capodanno D, Angiolillo DJ. Antiplatelet Therapy After Implantation of Bioresorbable Vascular Scaffolds: A Review of the Published Data, Practical Recommendations, and Future Directions. JACC Cardiovasc Interv. 2017 Mar 13;10(5):425-437. doi: 10.1016/j.jcin.2016.12.279. PMID 28279311
• Tamburino C, Latib A, van Geuns RJ, Sabate M, Mehilli J, Gori T, Achenbach S, Alvarez MP, Nef H, Lesiak M, Di Mario C, Colombo A, Naber CK, Caramanno G, Capranzano P, Brugaletta S, Geraci S, Araszkiewicz A, Mattesini A, Pyxaras SA, Rzeszutko L, Depukat R, Diletti R, Boone E, Capodanno D, Dudek D. Contemporary practice and technical aspects in coronary intervention with bioresorbable scaffolds: a E PMID 25599676
• Vanoverbeke L, Bennett J. Drug-eluting resorbable coronary scaffolds: a review of recent advances. Expert Opin Drug Deliv. 2025 Jul;22(7):919-933. doi: 10.1080/17425247.2025.2495043. Epub 2025 Apr 20. PMID 40238640
• Power DA, Camaj A, Kereiakes DJ, Ellis SG, Gao R, Kimura T, Ali ZA, Stockelman KA, Dressler O, Onuma Y, Serruys PW, Stone GW; ABSORB Investigators. Early and Late Outcomes With the Absorb Bioresorbable Vascular Scaffold: Final Report From the ABSORB Clinical Trial Program. JACC Cardiovasc Interv. 2025 Jan 13;18(1):1-11. doi: 10.1016/j.jcin.2024.08.050. PMID 39814482

Identifiers

NCT: NCT07038408 · Leave Nothing Behind

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗