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

Icahn School of Medicine at Mount Sinai30 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

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)

Time frame: day 1

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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).

Time frame: day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.