Clinical trial NCT02364778: Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease
Official title: ORBID Trial: Three-Dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch Vessel After Provisional Main Vessel Stenting in Coronary Artery Stenting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: CAD
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2015-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: MLD SB Diameter
timeFrame: day 1
Secondary outcomes:
measure: SB Angle
timeFrame: day 1
measure: SB Ostial Involvement
timeFrame: day 1
measure: Diameter Stenosis (DS)
timeFrame: day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annapoorna Kini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kini AS, Vengrenyuk Y, Pena J, Yoshimura T, Panwar SR, Motoyama S, Kezbor S, Hasan CM, Palkhiwala S, Kovacic JC, Moreno P, Baber U, Mehran R, Narula J, Sharma SK. Plaque morphology predictors of side branch occlusion after provisional stenting in coronary bifurcation lesion: Results of optical coherence tomography bifurcation study (ORBID). Catheter Cardiovasc Interv. 2017 Feb 1;89(2):259-268. doi: 10.1002/ccd.26524. Epub 2016 Mar 31.