The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations

NCT06822322 | Not Yet Recruiting

• 1 other identifier: EBC DCB
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Coronary Artery Disease (non-left Main); Coronary Bifurcation Lesion

Keywords

non-left coronary bifurcation; drug coated balloon; drug eluted stent

Outcome Measures

Primary Outcomes (1)

• Bifurcation Orientated Composite Endpoint (BOCE)

  The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation

  At 1-year, after the day of enrollment

Secondary Outcomes (7)

• Bifurcation Orientated Composite Endpoint (BOCE)

  At 3, 5 and 8-years

• Individual components of the Primary Endpoint

  At 1, 3, 5 and 8-years

• Safety Composite Endpoint

  At 1, 3, 5 and 8-years

• Individual components of the Safety Composite Endpoint

  At 1, 3, 5 and 8-years

• BARC 3 or 5 bleeding rate

  At 1, 3, 5 and 8-years

Study Arms (2)

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.

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.

Procedure: Percutaneous Coronary Angioplasty; Device: Drug Coated Balloon Strategy; Device: Cross-Over Stepwise Provisional Stent Strategy

Interventions

Percutaneous Coronary Angioplasty PROCEDURE

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.

Drug Coated Balloon Strategy; Stepwise Provisional Stent Strategy

Stepwise Provisional Stent Strategy DEVICE

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).

Stepwise Provisional Stent Strategy

Drug Coated Balloon Strategy DEVICE

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.

Drug Coated Balloon Strategy

Cross-Over Stepwise Provisional Stent Strategy DEVICE

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.

Drug Coated Balloon Strategy

Eligibility Criteria

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

You may qualify if:

• 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:
• 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.

You may not qualify if:

• Patients \<18 years old
• STEMI \<48 hours
• Cardiogenic shock
• Chronic total occlusion involving target bifurcation vessels
• In-stent restenosis
• Patient life expectancy \<12 months
• \>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

Sponsors & Collaborators

• Ceric Sàrl: lead
• European Cardiovascular Research Center: collaborator

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  PMID: 35595676 BACKGROUND

• Lassen JF, Albiero R, Johnson TW, Burzotta F, Lefevre T, Iles TL, Pan M, Banning AP, Chatzizisis YS, Ferenc M, Dzavik V, Milasinovic D, Darremont O, Hildick-Smith D, Louvard Y, Stankovic G. Treatment of coronary bifurcation lesions, part II: implanting two stents. The 16th expert consensus document of the European Bifurcation Club. EuroIntervention. 2022 Aug 19;18(6):457-470. doi: 10.4244/EIJ-D-22-00166.

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• Burzotta F, Lassen JF, Louvard Y, Lefevre T, Banning AP, Daremont O, Pan M, Hildick-Smith D, Chieffo A, Chatzizisis YS, Dzavik V, Gwon HC, Hikichi Y, Murasato Y, Koo BK, Chen SL, Serruys P, Stankovic G. European Bifurcation Club white paper on stenting techniques for patients with bifurcated coronary artery lesions. Catheter Cardiovasc Interv. 2020 Nov;96(5):1067-1079. doi: 10.1002/ccd.29071. Epub 2020 Jun 24.

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• Louvard Y, Thomas M, Dzavik V, Hildick-Smith D, Galassi AR, Pan M, Burzotta F, Zelizko M, Dudek D, Ludman P, Sheiban I, Lassen JF, Darremont O, Kastrati A, Ludwig J, Iakovou I, Brunel P, Lansky A, Meerkin D, Legrand V, Medina A, Lefevre T. Classification of coronary artery bifurcation lesions and treatments: time for a consensus! Catheter Cardiovasc Interv. 2008 Feb 1;71(2):175-83. doi: 10.1002/ccd.21314.

  PMID: 17985377 BACKGROUND

Related Links

• U.S. Food and Drug Administration. Medtronic Resolute Onyx Stent - Premarket Approval (PMA)
• Sealed Envelope \| Power calculator for binary outcome non-inferiority trial

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• David HILDICK-SMITH, Prof., MD

  Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basile GRAVEZ, PhD

CONTACT

+33 (0)789452048; bgravez@cerc-europe.org

Laure MORSIANI, PhD

CONTACT

+33 (0)176739236; lmorsiani@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

Model Details: Post-market study to compare Drug Coated Balloon versus Drug Eluted Stent.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 12, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2035
• Last Updated: February 14, 2025

Record last verified: 2025-02