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

NCT07038408 | Recruiting DMC

• 1 other identifier: Leave Nothing Behind
• Study Type: interventional
• Target: 2,256
• Locations: 1 country
• Sites: 1

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. 1.st FU visit - 1 month (in hospital)
2. 2.nd FU visit - 6 months (telephone)
3. 3.rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
4. 4.th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
5. 5.th FU visit - 730 days±30 days (telephone call) - 2Y
6. 6.th FU visit - 1095 days±30 days (telephone call) - 3Y
7. 7.th FU visit - 1460 days±30 days (telephone call) - 4Y
8. 8.th FU visit- 1825 days±30 days (telephone call) - 5Y

Conditions

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

Keywords

MULTI-CENTER; OPEN-LABEL; PROSPECTIVE; RANDOMIZED STUDY; LONG-TERM EFFICACY OF DCB TREATMENT WITH BAIL-OUT BRS; BRS TREATMENT; DE-NOVO NATIVE CORONARY ARTERY LESIONS; YOUNG PCI POPULATION

Outcome Measures

Primary Outcomes (1)

• Target-vessel Failure (TVF)

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

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (4)

• 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-Lesion Failure (TLF)

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

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

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

• Net Adverse Clinical Event (NACE)

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

Other Outcomes (3)

• Acute Gain

  From enrollment to the end of treatment at 13 months

• Late Loss

  From enrollment to the end of treatment at 13 months

• In-segment Late Lumen Loss (LLL)

  From enrollment to the end of treatment at 13 months

Study Arms (2)

DCB treatment (Mozec SEB)

EXPERIMENTAL

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.

Procedure: Angioplasty with DCB (bail-out BRS)

BRS treatment (MeRes100)

ACTIVE COMPARATOR

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

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

Interventions

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.

Also known as: DCB arm with bail-out BRS

BRS treatment (MeRes100); DCB treatment (Mozec SEB)

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.

Also known as: BRS arm

BRS treatment (MeRes100)

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ceric Sàrl: lead

Study Sites (1)

Põhja-Eesti Regionaalhaigla

Tallinn, 13419, Estonia

RECRUITING

Related Publications (13)

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  PMID: 40114731 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 European perspective. EuroIntervention. 2015 May;11(1):45-52. doi: 10.4244/EIJY15M01_05.

  PMID: 25599676 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.

  PMID: 32473887 BACKGROUND

• Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013 Jan 17;368(3):254-65. doi: 10.1056/NEJMra1210816. No abstract available.

  PMID: 23323902 BACKGROUND

• Zhang YJ, Bourantas CV, Muramatsu T, Iqbal J, Farooq V, Diletti R, Campos CA, Onuma Y, Garcia-Garcia HM, Serruys PW. Comparison of acute gain and late lumen loss after PCI with bioresorbable vascular scaffolds versus everolimus-eluting stents: an exploratory observational study prior to a randomised trial. EuroIntervention. 2014 Oct;10(6):672-80. doi: 10.4244/EIJV10I6A118.

  PMID: 24472767 BACKGROUND

• Asano T, Serruys PW, Collet C, Miyazaki Y, Takahashi K, Chichareon P, Katagiri Y, Modolo R, Tenekecioglu E, Morel MA, Garg S, Wykrzykowska J, Piek JJ, Sabate M, Morice MC, Chevalier B, Windecker S, Onuma Y. Angiographic late lumen loss revisited: impact on long-term target lesion revascularization. Eur Heart J. 2018 Sep 21;39(36):3381-3389. doi: 10.1093/eurheartj/ehy436.

  PMID: 30124834 BACKGROUND

• Madhavan MV, Kirtane AJ, Redfors B, Genereux P, Ben-Yehuda O, Palmerini T, Benedetto U, Biondi-Zoccai G, Smits PC, von Birgelen C, Mehran R, McAndrew T, Serruys PW, Leon MB, Pocock SJ, Stone GW. Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 Feb 18;75(6):590-604. doi: 10.1016/j.jacc.2019.11.058.

  PMID: 32057373 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

DAVIDE CAPODANNO, Professor

CONTACT

+39-3393238566; dcapodanno@unict.it

CERC France

CONTACT

LeaveNothingBehind@cerc-europe.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 26, 2025
• Study Start: April 24, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): March 1, 2032
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)