Keep bIfurcation Single Stenting Simple

Study Overview
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Brief Summary
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KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

Detailed Description
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In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when MB is treated according to the Murray law with a Proximal Optimization Technique (POT), remains unclear. The KISS study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique.

Official Title
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A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion

Conditions
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Coronary Disease

Intervention / Treatment
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* Procedure: Side branch protection/ballooning
* Procedure: No side branch protection/ballooning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery disease requiring revascularization that is amenable to percutaneous coronary intervention (PCI) Any de novo Medina type bifurcation lesion with >70% lesion in the main vessel by visual assessment except Medina 0,0,1 if the planned strategy does not include a main branch stenting Side branch diameter compatible with a PCI with stent implantation (≥ 2.25mm) Side branch requiring a protection wire according to operator evaluation Anatomy compatible with a proximal optimization technique Post main branch treatment (stenting then POT): Absence of side branch occlusion Or low flow associated with ongoing ischemia (either chest pain or ST changes) Male or female patient >18 years old Exclusion Criteria: Acute myocardial infarction with ongoing ST-elevation Cardiogenic shock Requirement for ongoing hemodialysis Life-expectancy limited to <12 months due to co-morbid condition Lesion involves the left main coronary artery Lesion requiring a double stenting Plan to treat >1 other coronary vessel at the time of the index procedure Two lesions treated in the same session: unsuccessful PCI on the single non bifurcation lesion in a non-target vessel before the treatment of the target lesion. Chronic total occlusion of any target vessel Left ventricular ejection fraction <20% Side branch TIMI Flow <3 Pre-dilatation of the Side Branch during the procedure prior to randomization Known allergy to Aspirin Known allergy to Clopidorel and Prasugrel and Ticagrelor Known allergy to stent drug elutant Known allergy to any other component of Onyx Resolute stent Ongoing participation in another investigational device or drug study Inability to provide informed consent Patients under judicial protection, tutorship or curatorship Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures

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 |
| --- | --- |
| Experimental: Test group<br>No intervention on the side branch in the context of percutaneous coronary intervention for the treatment of bifurcation lesion | Procedure: No side branch protection/ballooning<br>* No intervention on the side branch<br>|
| Active Comparator: Control group<br>Side branch protection: Ballooning or Kissing Balloon Technique, in the context of percutaneous coronary intervention for the treatment of bifurcation lesion | Procedure: Side branch protection/ballooning<br>* Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periprocedural Myocardial infarction | Rate of peri-procedural Myocardial Infarction (MI) at discharge or 48 hours post-procedure whichever comes first as judged by clinical evaluation in association with day-1 troponin evaluation using the ARC-2 definition | up to 48 hours post-procedure, up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success (1) | Deployment of main branch (MB) stent with <20% residual stenosis and a patent side branch at end of procedure upon corelab analysis | Intraoperative, up to 12 months | 
| Technical success (2) | Total procedure time | Intraoperative, up to 12 months | 
| Technical success (3) | Acute gain in main and side branches as measured with a dedicated quantitative coronary analysis (QCA) software | up to 12 months | 
| Technical success (4) | Fluoroscopy time | Intraoperative, up to 12 months | 
| Technical success (5) | Total radiation dose (air kerma) | Intraoperative, up to 12 months | 
| Technical success (6) | Total contrast dose | Intraoperative, up to 12 months | 
| Technical success (6) | Need to cross over (any intervention on SB in the test arm or failure to intervene on the SB in the control arm) | Intraoperative, up to 12 months | 
| Target Lesion Failure (TLF) | Composite of: Cardiac Death Target vessel Myocardial Infarction Clinically driven Target lesion revascularization (ci-TLR) | 1 month and 12 months | 
| Target Lesion Revascularization (TLR) | Main Branch & Side Branch TLR | 1 month and 12 months | 
| Stent thrombosis: | Definite or Probable stent thrombosis (ARC-2 criteria) | 1 month and 12 months | 
| Angina status | Angina status according to the Canadian Cardiovascular Society (CCS) classification (Grade 1 to 4) | 1 month and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary disease, Bifurcation lesion