Comparison of Results Achieved by Different Ballooning Techniques in Bifurcation Stenting

Study Overview
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Brief Summary
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Single-stent strategy with provisional approach represents the gold standard for percutaneous coronary intervention of bifurcation lesions, and, according to European Bifurcation Club, performing provisional approach presents two steps considered as mandatory: crossover stenting in main vessel (MV) and subsequent post-dilation or POT (proximal optimization technique). While consensus exists regarding these first two steps, the exact optimal following sequence in case of side branch (SB) jeopardize after main vessel stenting is still a matter of debate. Actually, the two most used techniques in this setting are represented by the simultaneous inflation of two balloons located respectively in the MV and SB followed by a second POT (POT/kissing balloon/POT technique) and the isolated inflation of a balloon placed in the SB followed by a second POT (POT/SIDE/POT technique). The objective of this study is to compare the configuration achieved with POT/KISS/POT (PKP) and POT/SIDE/POT (PSP), using the cutting edge high-resolution intracoronary imaging modality (Optical Coherence Tomography, OCT).

Detailed Description
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A preclinical phase of the study (CRABBS-VHL) was performed in isolated porcine hearts comparing the two common side-branch (SB) optimization techniques after stent implantation in the main vessel (MV): proximal optimization technique (POT) + kissing balloon inflation + final POT (PKP arm) and POT + isolated balloon inflation + final POT (PSP arm). A total of 30 PCIs were successfully performed. Baseline characteristics of treated bifurcations were similar between the two study arms. Minimum stent expansion at the distal main vessel (MV) segment was significantly lower with PSP as compared with PKP as assessed by both OCT and Micro-CT . Other significant findings included: higher stent eccentricity index at proximal MV with PSP, higher SB scaffolding length and lower malapposition (at bifurcation core and distal MV) with PKP. These data need to be confirmed by further randomized studies in humans.

Official Title
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Head-to-head Comparison of Stent Geometry Obtained by Different Ballooning Techniques in Large Bifurcations Treated by Provisional Stenting

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Diagnostic Test: OCT


Participation Criteria
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Eligibility Criteria
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Clinical inclusion criteria: Subject has coronary artery disease involving a bifurcation with evidence of myocardial ischemia, including patient with chronic coronary syndromes, unstable angina, or non-ST elevation-acute coronary syndromes (NSTE-ACS) hemodynamically stable. Subject is suitable to be treated by PCI according to operator's judgement or heart team decision. PCI planning includes provisional stenting and image guidance by OCT use. Patient is aged ≥ 18 years. Patient can provide written informed consent Angiographic inclusion criteria: - De novo coronary lesion involving the left main bifurcation, or a bifurcation lesion not located in the left main with large branches (distal MV reference diameter ≥ 3.5 mm and SB reference diameter ≥ 2.75 mm on visual estimation) Clinical exclusion criteria: Acute coronary syndromes with ST-elevation (STE-ACS) Cardiogenic shock LVEF ≤ 30% Pregnancy Known severe thrombocytopaenia (platelet count < 50,000/mm3) eGFR ≤ 30 mL/min/m2 (Cockcroft-Gault) Contraindications to antiplatelet drugs/anticoagulant drugs Significant allergic reactions for contrast agent Women with pregnancy potential. Angiographic exclusion criteria: Target chronic total occlusion Planned 2 stent-strategy Target bifurcation lesion has a previously implanted stent Target graft lesions Medina 0.0.1 target lesions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Interventional Model Description: Before enrollment start, the plausibility of the study hypothesis will be verified in an experimental pilot randomized investigation conducted n an ex-vivo beating heart animal model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: POT/KISSING/POT (PKP)<br>SB rewiring is performed with the objective to cross distal stent struts (distal rewiring) through pullback technique. KBI is performed using short non-compliant balloons (balloon of MV sized in a 1:1 ratio with distal MV reference diameter and SB balloon sized in a 1:1 ratio with SB reference diameter), with sequential followed by simultaneous inflation. Final POT is performed at the same way as initial POT | Diagnostic Test: OCT<br>* OCT will be used to assess results after intervention<br>|
| Active Comparator: POT/SIDE/POT (PSP)<br>SB rewiring is performed with the objective to cross distal stent struts (distal rewiring) through pullback technique. SB dilatation is performed with a balloon sized 1:1 according to SB reference diameter. Final POT is performed at the same way as initial POT. | Diagnostic Test: OCT<br>* OCT will be used to assess results after intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent expansion | Minimum stent expansion | Intra-procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side branch ostial scaffolding length | difference between maximal stent diameter at bifurcation core and distal reference diameter | Intra-procedural | 
| Stent eccentricity index | SEI = minimum stent diameter/maximum stent diameter | Intra-procedural | 
| Stent complications | Stent under-expansion | Intra-procedural | 
| Additional treatment after OCT | need of additional treatment after assessment of results by OCT | Intra-procedural | 
| Stent malapposition | Stent malapposition | Intra-procedural | 
| Stent proximal edge dissection | Stent proximal edge dissection | Intra-procedural | 
| Tissue prolapse | Tissue prolapse | Intra-procedural | 
| Intracoronary thrombus | Intracoronary thrombus | Intra-procedural | 
| Side branch ostium dissection | Side branch ostium dissection | Intra-procedural | 
| Stent complicatons | In-stent dissection | Intra-procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Provisional, OCT, kissing balloon, bifurcations