Drug Coated BalloonLNBNCT07038408
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
A study testing Angioplasty with DCB (bail-out BRS) and Angioplasty with BRS in people with Drug Coated Balloon and Bioresorbable Scaffold, run by Ceric Sàrl at 1 site in Estonia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Angioplasty with DCB (bail-out BRS) and Angioplasty with BRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,256 participants
- Where
- 1 siteEstonia
- Study dates
- 24 Apr 2026to Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
CERC France contact
Estonia1 site, 1 recruiting
- Recruiting
Põhja-Eesti Regionaalhaigla
Tallinn, 13419
Peep Laanmets
About this study
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.
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?
Read more
Participants will be followed at:
- st FU visit - 1 month (in hospital)
- nd FU visit - 6 months (telephone)
- rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
- th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
- th FU visit - 730 days±30 days (telephone call) - 2Y
- th FU visit - 1095 days±30 days (telephone call) - 3Y
- th FU visit - 1460 days±30 days (telephone call) - 4Y
- th FU visit- 1825 days±30 days (telephone call) - 5Y
Read the 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.
- Conditions
- Drug Coated Balloon, Bioresorbable Scaffold, Percutaneous Coronary Intervention (PCI), Acute Coronary Syndrome (ACS)
- Being tested
- Angioplasty with DCB (bail-out BRS), Angioplasty with BRS
- 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
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty with DCB (bail-out BRS)Procedure or surgery
Also called DCB arm with 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 BRSProcedure or surgery
Also called BRS arm
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Angioplasty with DCB (bail-out BRS); Procedure: Angioplasty with BRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (4)
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
Measured: From enrollment to the end of treatment at every year from 2 years until 5 years follow-up
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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment every year until end of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start24 Apr 2026
- Primary completion30 Nov 2028 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Drug Coated BalloonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038408
- Sponsor's protocol ID
- Leave Nothing Behind
- Acronym
- LNB
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40114731Abizaid 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.
PubMed 33269506Seth 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.
PubMed 31147308Premchand 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.
PubMed 40051667Capodanno 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.
PubMed 28279311Tamburino 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.
PubMed 25599676Vanoverbeke 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.
PubMed 40238640Power 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.
PubMed 39814482Jeger 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.
PubMed 32473887Stefanini 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.
PubMed 23323902Zhang 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.
PubMed 24472767Asano 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.
PubMed 30124834Madhavan 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.
PubMed 32057373
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07038408
- Acronym / sponsor ID
- LNB / Leave Nothing Behind
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,256 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- st FU visit - 1 month (in hospital)
- nd FU visit - 6 months (telephone)
- rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
- th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
- th FU visit - 730 days±30 days (telephone call) - 2Y
- th FU visit - 1095 days±30 days (telephone call) - 3Y
- th FU visit - 1460 days±30 days (telephone call) - 4Y
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB treatment (Mozec SEB) | Experimental | Procedure: Angioplasty with DCB (bail-out BRS)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 | Procedure: Angioplasty with DCB (bail-out BRS), Procedure: Angioplasty with BRSMeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angioplasty with DCB (bail-out BRS)Also: DCB arm with bail-out BRSAngioplasty 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. | Procedure or surgery | BRS treatment (MeRes100), DCB treatment (Mozec SEB) |
| Angioplasty with BRSAlso: BRS armBail-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. | Procedure or surgery | BRS treatment (MeRes100) |
Primary outcome
Target-vessel Failure (TVF)
Time frame: 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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 40114731Verma 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.
- Background: PubMed 33269506Abizaid 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.
- Background: PubMed 31147308Seth 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.
- Background: PubMed 40051667Premchand 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.
- Background: PubMed 28279311Capodanno 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.
- Background: PubMed 25599676Tamburino 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.
- Background: PubMed 40238640Vanoverbeke 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.
- Background: PubMed 39814482Power 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.
- Background: PubMed 32473887Jeger 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.
- Background: PubMed 23323902Stefanini 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.
- Background: PubMed 24472767Zhang 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.
- Background: PubMed 30124834Asano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CERC France contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioplasty with DCB (bail-out BRS) and Angioplasty with BRS in people with Drug Coated Balloon and Bioresorbable Scaffold, run by Ceric Sàrl at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAVIDE CAPODANNO, Professor (+39-3393238566, dcapodanno@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target-vessel Failure (TVF) (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07038408, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.