Coronary Artery Disease (non-left Main)EBC DCBNCT06822322
The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
A study testing Percutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy and Drug Coated Balloon Strategy in people with Coronary Artery Disease (non-left Main) and Coronary Bifurcation Lesion, run by Ceric Sàrl.
Trial summary
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (non-left Main), Coronary Bifurcation Lesion
- What is being tested?
- Percutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy and Drug Coated Balloon Strategy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Aug 2035
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
- Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:
- ≥70% angiographic MV and SB diameter stenosis
- Positive non-invasive testing for ischaemia
- Positive coronary physiology for ischaemia
- Significant SB as described by diameter stenosis ≥50% and all of the following:
Show all 10Show fewer
- SB length ≥73mm
- SB diameter ≥2.5mm
- Absence of another SB emerging distally from the MV
- Non-dominant circumflex artery, if SB is a diagonal branch.
Who cannot join
- Patients <18 years old
- STEMI <48 hours
- Cardiogenic shock
- Chronic total occlusion involving target bifurcation vessels
- In-stent restenosis
- Patient life expectancy <12 months
Show all 12Show fewer
- >2 other coronary lesions (target or non-target) planned for treatment
- SYNTAX score >32
- Platelet count ≤50x109/mm3
- Left ventricular ejection fraction ≤20%
- Participation in another investigational drug or device study
- Patient unable to give informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.
Read the detailed description
The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial.
Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included.
Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).
- Being tested
- Percutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy, Drug Coated Balloon Strategy, Cross-Over Stepwise Provisional Stent Strategy
- Keywords
- non-left coronary bifurcation, drug coated balloon, drug eluted stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary AngioplastyProcedure or surgery
A Percutaneous Coronary Intervention is used in both arms, with the drug Zotarolimus for stenting strategy and Paclitaxel for balloon strategy.
Coronary guide wires are passed into both the distal main vessel (distal MV) and side branch (SB) and predilation of MV on a 1:1 basis is required.
The device component dilates the vessel lumen by Percutaneous Transluminal Coronary Angioplasty (PTCA), while the drug is intended to reduce the proliferative response associated with restenosis.
Stepwise Provisional Stent StrategyDevice
In the stepwise provisional stent strategy, stenting of the MV is undertaken with a wire jailed in the SB. Then, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure (kissing balloon inflation ; KBI).
Drug Coated Balloon StrategyDevice
In the drug coated balloon (DCB) strategy, SB is prepared with a balloon at a 1:1 diameter, followed with a 1:1 sized DCB inflation for 60 seconds at nominal pressure. Then, MV is re-evaluated and treated with DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds.
Cross-Over Stepwise Provisional Stent StrategyDevice
Following Drug Coated Balloon treatment in the Main vessel (MV) in the Drug Coated Balloon Arm, if the result is unacceptable in the MV, with either TIMI>3 flow and/or dissection propagation, MV stenting is mandatory followed with Kissing Balloon Inflation (KBI), where non-compliant balloons sized to the diameter of the distal main and side branch are sequentially inflated at high pressure, and then simultaneously at low pressure. If the cross-over stent implantation in the MV is used, a further SB treatment with either DCB or stent implantation is used, according to operator preference.
| Study group | Role | What they receive |
|---|---|---|
| Stepwise Provisional Stent Strategy | Active comparator | Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). Stenting of the MV is undertaken with a wire jailed in the SB to preserve SB flow and access. Stent diameter is chosen according to the diameter of the distal MV. Following stent deployment, the stent portion in the proximal MV is dilated with a short non-compliant balloon (POT technique) to achieve full expansion and apposition.
Finally, after POT technique, SB is rewired and a kissing balloon inflation (KBI) is undertaken to address any plaque or carina shift and to open stent struts. Thus, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure.
Further SB treatment is required only if <TIMI 3 flow, significant stenosis >70% or significant dissection. Thus, a side vessel stent implantation followed with KBI are mandatory. Receives: Procedure: Percutaneous Coronary Angioplasty; Device: Stepwise Provisional Stent Strategy |
| Drug Coated Balloon Strategy | Experimental | Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains >30%, or TIMI flow<3, or dissection propagation, the stenting of the MV is mandatory.
Otherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure.
If residual stenosis remains >50%, or TIMI flow<3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB.
After SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory.
The procedure is complete when the MV has residual stenosis <30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis <50%, has TIMI 3 flow and has no dissection propagation. Receives: Procedure: Percutaneous Coronary Angioplasty; Device: Drug Coated Balloon Strategy; Device: Cross-Over Stepwise Provisional Stent Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifurcation Orientated Composite Endpoint (BOCE)
The BOCE is defined by:
- cardiovascular death,
- target bifurcation-related myocardial infarction or
- target bifurcation revascularisation
Measured: At 1-year, after the day of enrollment
Secondary outcomes (7)
Bifurcation Orientated Composite Endpoint (BOCE)
BOCE non-inferiority and superiority
Measured: At 3, 5 and 8-years
Individual components of the Primary Endpoint
- cardiovascular death
- target bifurcation-related myocardial infarction
- target bifurcation revascularisation
Measured: At 1, 3, 5 and 8-years
Safety Composite Endpoint
- Safety Composite Endpoint defined as:
- BARC bleeding (2/3/5)
- Definite stent/lesion thrombosis
- Stroke
- MI
- All-cause mortality
Measured: At 1, 3, 5 and 8-years
Individual components of the Safety Composite Endpoint
- BARC bleeding (2/3/5)
- Definite stent/lesion thrombosis
- Stroke
- MI
- All-cause mortality
Measured: At 1, 3, 5 and 8-years
BARC 3 or 5 bleeding rate
BARC 3 or 5 bleeding rate
Measured: At 1, 3, 5 and 8-years
Angina status
Questionnaire: Seattle Angina Questionnaire - 7 (SAQ-7) Scale Range (Minimum and Maximum Values): 0 to 100 Higher scores indicate a better outcome (better health status, less angina, and better quality of life).
Measured: At 1, 3, 5 and 8-years
Angina index
No. of antianginals
Measured: At 1, 3, 5 and 8-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionAug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (64)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (non-left Main)Studies of the same condition, open and under way.
- More trials run by Ceric SàrlThe sponsor's other registered studies.
- 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
- Model description
- Post-market study to compare Drug Coated Balloon versus Drug Eluted Stent.
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ceric Sàrl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- David HILDICK-SMITH, Prof., MD, Principal investigator, Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822322
- Sponsor's protocol ID
- EBC DCB
- Acronym
- EBC DCB
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
PubMed 30170854Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
PubMed 26457558Hildick-Smith D, Behan MW, Lassen JF, Chieffo A, Lefevre T, Stankovic G, Burzotta F, Pan M, Ferenc M, Bennett L, Hovasse T, Spence MJ, Oldroyd K, Brunel P, Carrie D, Baumbach A, Maeng M, Skipper N, Louvard Y. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations. Circ Cardiovasc Interv. 2016 Sep;9(9):e003643. doi: 10.1161/CIRCINTERVENTIONS.115.003643.
PubMed 27578839Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.
PubMed 20194880Konishi H, Habara M, Nasu K, Koshida R, Kinoshita Y, Tsuchikane E, Terashima M, Matsubara T, Suzuki T. Impact of Optimal Preparation Before Drug-Coated Balloon Dilatation for De Novo Lesion in Patients With Coronary Artery Disease. Cardiovasc Revasc Med. 2022 Feb;35:91-95. doi: 10.1016/j.carrev.2021.03.012. Epub 2021 Mar 20.
PubMed 33766488Jeger 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 32473887Ninomiya K, Serruys PW, Colombo A, Reimers B, Basavarajaiah S, Sharif F, Testa L, Di Mario C, Nerla R, Ding D, Huang J, Kotoku N, Kageyama S, Kageyama M, Sevestre E, Fezzi S, Dijkstra J, O'Leary N, Morel MA, Garg S, Cortese B, Onuma Y. A Prospective Randomized Trial Comparing Sirolimus-Coated Balloon With Paclitaxel-Coated Balloon in De Novo Small Vessels. JACC Cardiovasc Interv. 2023 Dec 11;16(23):2884-2896. doi: 10.1016/j.jcin.2023.09.026. Epub 2023 Oct 23.
PubMed 37877914Latib A, Agostoni P, Dens J, Patterson M, Lancellotti P, Tam FCC, Schotborgh C, Kedhi E, Stella P, Shen C, Wetzels G, Testa L; PREVAIL Study Investigators. Paclitaxel Drug-Coated Balloon for the Treatment of De Novo Small-Vessel and Restenotic Coronary Artery Lesions: 12-Month Results of the Prospective, Multicenter, Single-Arm PREVAIL Study. J Invasive Cardiol. 2021 Nov;33(11):E863-E869. doi: 10.25270/jic/21.00119. Epub 2021 Aug 19.
PubMed 34433695Widder JD, Cortese B, Levesque S, Berliner D, Eccleshall S, Graf K, Doutrelant L, Ahmed J, Bressollette E, Zavalloni D, Piraino D, Roguin A, Scheller B, Stella PR, Bauersachs J. Coronary artery treatment with a urea-based paclitaxel-coated balloon: the European-wide FALCON all-comers DCB Registry (FALCON Registry). EuroIntervention. 2019 Jul 20;15(4):e382-e388. doi: 10.4244/EIJ-D-18-00261.
PubMed 29992902Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14.
PubMed 23158530Gao XF, Ge Z, Kan J, Kong XQ, Wang Y, Qiu CG, Tresukosol D, He YQ, Wu Q, Li JF, Yuan HT, Shen C, Chen X, Munawar M, Hanif B, Santoso T, Shin ES, Sheiban I, Ye F, Zhang JJ, Chen SL; DCB-BIF investigators. Rationale and design for comparison of non-compliant balloon with drug-coating balloon angioplasty for side branch after provisional stenting for patients with true coronary bifurcation lesions: a prospective, multicentre and randomised DCB-BIF trial. BMJ Open. 2022 Mar 11;12(3):e052788. doi: 10.1136/bmjopen-2021-052788.
PubMed 35277400Kleber FX, Rittger H, Ludwig J, Schulz A, Mathey DG, Boxberger M, Degenhardt R, Scheller B, Strasser RH. Drug eluting balloons as stand alone procedure for coronary bifurcational lesions: results of the randomized multicenter PEPCAD-BIF trial. Clin Res Cardiol. 2016 Jul;105(7):613-21. doi: 10.1007/s00392-015-0957-6. Epub 2016 Jan 14.
PubMed 26768146Bruch L, Zadura M, Waliszewski M, Platonic Z, Eranen J, Scheller B, Gotting B, Herberger D, Palmieri C, Sinicropi G, Motz W. Results From the International Drug Coated Balloon Registry for the Treatment of Bifurcations. Can a Bifurcation Be Treated Without Stents? J Interv Cardiol. 2016 Aug;29(4):348-56. doi: 10.1111/joic.12301. Epub 2016 May 31.
PubMed 27242273Schulz A, Hauschild T, Kleber FX. Treatment of coronary de novo bifurcation lesions with DCB only strategy. Clin Res Cardiol. 2014 Jun;103(6):451-6. doi: 10.1007/s00392-014-0671-9. Epub 2014 Feb 14.
PubMed 24522798Vos NS, Fagel ND, Amoroso G, Herrman JR, Patterson MS, Piers LH, van der Schaaf RJ, Slagboom T, Vink MA. Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1691-1699. doi: 10.1016/j.jcin.2019.04.016. Epub 2019 May 21.
PubMed 31126887
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study
- ClinicalTrials.gov ID
- NCT06822322
- Acronym / sponsor ID
- EBC DCB / EBC DCB
- Keywords
- non-left coronary bifurcation, drug coated balloon, drug eluted stent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Ceric SàrlIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- May 2025 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2035 (estimated)
- First posted
- 12 Feb 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.
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.
Detailed description
The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial.
Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included.
Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Post-market study to compare Drug Coated Balloon versus Drug Eluted Stent.
| Arm | Type | Receives |
|---|---|---|
| Stepwise Provisional Stent Strategy | Active comparator | Procedure: Percutaneous Coronary Angioplasty, Device: Stepwise Provisional Stent StrategyCoronary guide wires are passed into both the main vessel (MV) and side branch (SB). Stenting of the MV is undertaken with a wire jailed in the SB to preserve SB flow and access. Stent diameter is chosen according to the diameter of the distal MV. Following stent deployment, the stent portion in the proximal MV is dilated with a short non-compliant balloon (POT technique) to achieve full expansion and apposition. Finally, after POT technique, SB is rewired and a kissing balloon inflation (KBI) is undertaken to address any plaque or carina shift and to open stent struts. Thus, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure. Further SB treatment is required only if <TIMI 3 flow, significant stenosis >70% or significant dissection. Thus, a side vessel stent implantation followed with KBI are mandatory. |
| Drug Coated Balloon Strategy | Experimental | Procedure: Percutaneous Coronary Angioplasty, Device: Drug Coated Balloon Strategy, Device: Cross-Over Stepwise Provisional Stent StrategyCoronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains >30%, or TIMI flow<3, or dissection propagation, the stenting of the MV is mandatory. Otherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure. If residual stenosis remains >50%, or TIMI flow<3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB. After SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory. The procedure is complete when the MV has residual stenosis <30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis <50%, has TIMI 3 flow and has no dissection propagation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
- Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:
- Significant SB as described by diameter stenosis ≥50% and all of the following:
Key exclusion criteria (12 listed)
- Patients <18 years old
- STEMI <48 hours
- Cardiogenic shock
- Chronic total occlusion involving target bifurcation vessels
- In-stent restenosis
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 |
|---|---|---|
| Percutaneous Coronary AngioplastyA Percutaneous Coronary Intervention is used in both arms, with the drug Zotarolimus for stenting strategy and Paclitaxel for balloon strategy. Coronary guide wires are passed into both the distal main vessel (distal MV) and side branch (SB) and predilation of MV on a 1:1 basis is required. The device component dilates the vessel lumen by Percutaneous Transluminal Coronary Angioplasty (PTCA), while the drug is intended to reduce the proliferative response associated with restenosis. | Procedure or surgery | Drug Coated Balloon Strategy, Stepwise Provisional Stent Strategy |
| Stepwise Provisional Stent StrategyIn the stepwise provisional stent strategy, stenting of the MV is undertaken with a wire jailed in the SB. Then, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure (kissing balloon inflation ; KBI). | Device | Stepwise Provisional Stent Strategy |
| Drug Coated Balloon StrategyIn the drug coated balloon (DCB) strategy, SB is prepared with a balloon at a 1:1 diameter, followed with a 1:1 sized DCB inflation for 60 seconds at nominal pressure. Then, MV is re-evaluated and treated with DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. | Device | Drug Coated Balloon Strategy |
| Cross-Over Stepwise Provisional Stent StrategyFollowing Drug Coated Balloon treatment in the Main vessel (MV) in the Drug Coated Balloon Arm, if the result is unacceptable in the MV, with either TIMI>3 flow and/or dissection propagation, MV stenting is mandatory followed with Kissing Balloon Inflation (KBI), where non-compliant balloons sized to the diameter of the distal main and side branch are sequentially inflated at high pressure, and then simultaneously at low pressure. If the cross-over stent implantation in the MV is used, a further SB treatment with either DCB or stent implantation is used, according to operator preference. | Device | Drug Coated Balloon Strategy |
Primary outcome
Bifurcation Orientated Composite Endpoint (BOCE)
Time frame: At 1-year, after the day of enrollment
The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation
7 secondary outcomes
Bifurcation Orientated Composite Endpoint (BOCE)
Time frame: At 3, 5 and 8-years
Individual components of the Primary Endpoint
Time frame: At 1, 3, 5 and 8-years
Safety Composite Endpoint
Time frame: At 1, 3, 5 and 8-years
Individual components of the Safety Composite Endpoint
Time frame: At 1, 3, 5 and 8-years
BARC 3 or 5 bleeding rate
Time frame: At 1, 3, 5 and 8-years
Angina status
Time frame: At 1, 3, 5 and 8-years
Angina index
Time frame: At 1, 3, 5 and 8-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 14 Feb 2025.
- Background: PubMed 30170854Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.
- Background: PubMed 26457558Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
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- U.S. Food and Drug Administration. Medtronic Resolute Onyx Stent - Premarket Approval (PMA)Link provided by the sponsor.
- Sealed Envelope \| Power calculator for binary outcome non-inferiority trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
David HILDICK-SMITH, Prof., MD principal investigator
Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Angioplasty, Stepwise Provisional Stent Strategy and Drug Coated Balloon Strategy in people with Coronary Artery Disease (non-left Main) and Coronary Bifurcation Lesion, run by Ceric Sàrl.
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 10 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: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Basile GRAVEZ, PhD (+33 (0)789452048, bgravez@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bifurcation Orientated Composite Endpoint (BOCE) (time frame: At 1-year, after the day of enrollment). 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 NCT06822322, which also lists 64 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 14 Feb 2025.