Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| BRS treatment (MeRes100) | Active Comparator | MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years. | 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 every year from 2 years until 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Gain | Acute gain (in-lesion and in-segment) | From enrollment to the end of treatment at 13 months |
| Late Loss | Late loss (in-lesion and in-segment) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAVIDE CAPODANNO, Professor | Contact | +39-3393238566 | dcapodanno@unict.it | |
| CERC France | Contact | LeaveNothingBehind@cerc-europe.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Põhja-Eesti Regionaalhaigla | Recruiting | Tallinn | 13419 | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40114731 | Background | 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. | |
| 33269506 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
| Target-Lesion Failure (TLF) |
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 |
| From enrollment to the end of treatment every year until end of 5 years |
| (Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings | 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 | From enrollment to the end of treatment every year until end of 5 years |
| Net Adverse Clinical Event (NACE) | NACE defined as all-cause death, myocardial infarction, all-stroke, ischemia driven TVR or BARC 3 or 5 bleeding | From enrollment to the end of treatment every year until end of 5 years |
| From enrollment to the end of treatment at 13 months |
| In-segment Late Lumen Loss (LLL) | In segment LLL in vessels with RVD < 3.0 mm and ≥ 3.0 mm | From enrollment to the end of treatment at 13 months |
| 31147308 | 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. |
| 40051667 | 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. |
| 28279311 | 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. |
| 25599676 | 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. |
| 40238640 | 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. |
| 39814482 | 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. |
| 32473887 | 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. |
| 23323902 | 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. |
| 24472767 | 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. |
| 30124834 | 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. |
| 32057373 | 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. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
Not provided
Not provided