Treatment of Coronary Bifurcation Lesions: Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting

Study Overview
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Brief Summary
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Treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. While a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. Further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. Recent randomized data demonstrate the superiority of the technique called double kissing and crush (DK-Crush) over provisional stenting in this setting. The DK-Crush technique is however cumbersome, time-consuming and requires very experienced operators. The investigators therefore plan to undertake a randomized study comparing a novel interventional technique against DK-crush in the setting of true bifurcation lesions (Medina lesions type 1,1,1 or 0,1,1).

Official Title
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Treatment of Coronary Bifurcation Lesions: a Non-inferiority, Randomized, Controlled Procedural Outcomes Trial Comparing Reverse T and Protrusion Versus Double-kissing and Crush Stenting

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: DK crush
* Procedure: Reverse TAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the inclusion criteria: Documented heart team (as per guidelines) decision for revascularization via PCI Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches >2.5mm and with a stenosis >50% and clinical indication to percutaneous intervention, including: Ischemic symptoms, OR Positive non-invasive imaging for ischemia, OR Positive Flow Fractional Reserve (FFR), OR mean lumen area (MLA) <6mm^2 for the left main or <4mm^2 for epicardial vessels as assessed by intracoronary imaging (IVUS, OCT) Vessel diameter ≤5.00mm True bifurcation lesion type 1,1,1 or 0,1,1 Patient ≥18 years old Exclusion Criteria: Cardiogenic shock Trifurcation if all vessels are ≥2.75mm diameter Either bifurcation vessel not suitable for stenting History of stenting in target bifurcation lesion Participation in another investigational drug or device study Patient unable to give informed consent Women of child-bearing potential or lactating In-stent restenosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DK crush<br>Percutaneous revascularization of true coronary bifurcation stenosis (Medina 1,1,1 or 0,1,1) with double kissing and crush technique | Procedure: DK crush<br>* revascularization of true coronary bifurcation stenosis in DK crush technique<br>|
| Experimental: Reverse TAP<br>Percutaneous revascularization of true coronary bifurcation Stenosis (Medina 1,1,1 or 0,1,1) with reverse T and protrusion technique | Procedure: Reverse TAP<br>* revascularization of true coronary bifurcation stenosis in Reverse TAP technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Expansion in the side branch (defined as the vessel which received the first stent) | Ratio of the minimum stent area of the side branch and the maximum stent area of the side branch | through study completion, an average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Min. lumen Diameter in side branch | Minimum lumen Diameter in the side branch | through study completion, an average of 2 hours | 
| Percentage of Stenosis in side branch | Percentage of Stenosis in the side branch | through study completion, an average of 2 hours | 
| Procedural success | procedural success defined by angiographic success (no residual Stenosis of more than 20% at the end of Radiation) AND no periprocedural complications (including STEMI, new Q-wave myocardial infarction (MI), death, stent thrombosis, by-pass surgery, peri-procedural cardiac biomarker release according to the third universal definition of myocardial infarction) at discharge | through study completion, an average of 2 days | 
| fluoroscopy time | Time of radiation during intervention | through study completion, an average of 2 hours | 
| procedural time | time of procedure (Skin-to-Skin-time) | through study completion, an average of 2 hours | 
| use of coronary wires | amount of coronary wires used during procedure | through study completion, an average of 2 hours | 
| protocol success | the Intervention is performed according to the protocol (including final kissing PTCA) | through study completion, an average of 2 hours | 
| Min. lumen Diameter in main branch | Minimum lumen Diameter in the main branch | through study completion, an average of 2 hours | 
| Percentage of Stenosis in main branch | Percentage of Stenosis in the main branch | through study completion, an average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double kissing and crush, bifurcation coronary lesions, interventional technique of coronary lesions, DK crush, Reverse TAP, reverse T-and-protrusion