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

Mount Sinai Health System

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02364778

GCO 14-1777

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 1 patient group

Provisional stenting strategy

Description:

Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.