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

February 13, 2025 updated by: Ceric Sàrl

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stepwise Provisional Stent Strategy

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

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.

Device: Stepwise Provisional Stent Strategy
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).
Experimental: Drug Coated Balloon Strategy

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

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.

Device: Drug Coated Balloon Strategy
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.
Device: Cross-Over Stepwise Provisional Stent Strategy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 1-year, after the day of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bifurcation Orientated Composite Endpoint (BOCE)
Time Frame: At 3, 5 and 8-years
BOCE non-inferiority and superiority
At 3, 5 and 8-years
Individual components of the Primary Endpoint
Time Frame: At 1, 3, 5 and 8-years
  • cardiovascular death
  • target bifurcation-related myocardial infarction
  • target bifurcation revascularisation
At 1, 3, 5 and 8-years
Safety Composite Endpoint
Time Frame: At 1, 3, 5 and 8-years

- Safety Composite Endpoint defined as:

  • BARC bleeding (2/3/5)
  • Definite stent/lesion thrombosis
  • Stroke
  • MI
  • All-cause mortality
At 1, 3, 5 and 8-years
Individual components of the Safety Composite Endpoint
Time Frame: At 1, 3, 5 and 8-years
  • BARC bleeding (2/3/5)
  • Definite stent/lesion thrombosis
  • Stroke
  • MI
  • All-cause mortality
At 1, 3, 5 and 8-years
BARC 3 or 5 bleeding rate
Time Frame: At 1, 3, 5 and 8-years
BARC 3 or 5 bleeding rate
At 1, 3, 5 and 8-years
Angina index
Time Frame: At 1, 3, 5 and 8-years
No. of antianginals
At 1, 3, 5 and 8-years
Angina status
Time Frame: At 1, 3, 5 and 8-years
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).
At 1, 3, 5 and 8-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Collaborators

European Cardiovascular Research Center

Investigators

  • Principal Investigator: David HILDICK-SMITH, Prof., MD, Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2035

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBC DCB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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