The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
NCT ID: NCT06822322
Last Updated: 2025-02-14
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
750 participants
INTERVENTIONAL
2025-05-31
2035-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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).
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.
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.
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.
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.
Interventions
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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.
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).
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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European Cardiovascular Research Center
NETWORK
Ceric Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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David HILDICK-SMITH, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom
Central Contacts
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References
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