Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
NCT ID: NCT07038408
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
2256 participants
INTERVENTIONAL
2025-12-10
2032-03-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCB treatment (Mozec SEB)
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.
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 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.
BRS treatment (MeRes100)
MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm.
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 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.
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.
Interventions
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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 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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
68 Years
ALL
No
Sponsors
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Ceric Sàrl
INDUSTRY
Responsible Party
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Leave Nothing Behind
Identifier Type: -
Identifier Source: org_study_id
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