Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease

Study Overview
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Brief Summary
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This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.

Detailed Description
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Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned will be recruited. All the participants of the registry will receive same stent. OCT will be performed to analyze plaque morphology, SB size, SB angle and side branch ostial involvement.

Official Title
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ORBID Trial: Three-Dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch Vessel After Provisional Main Vessel Stenting in Coronary Artery Stenting

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age presenting with stable coronary artery disease. Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited Exclusion Criteria: Patient with lesion involving side branch ( >70 %) by angiogram and need pre-dilation. Patients with ostial left main artery lesions or ostial right coronary artery lesions Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding Known allergy to acetylsalicylic acid or clopidogrel. Planned surgery within 12 months. History of bleeding diathesis Major surgery within 15 days Life expectancy < 12 months. Patients with kidney dysfunction (CrCl<30)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Provisional stenting strategy<br>Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MLD SB Diameter | Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD) | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SB Angle | Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA) | day 1 | 
| SB Ostial Involvement | Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD) | day 1 | 
| Diameter Stenosis (DS) | Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS). | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAD