Optical Coherence Tomography Predictors of Functionally Significant Side Branch Compromise After Provisional Main Vessel Stenting In Calcific Coronary Artery Disease Assessed by Fractional Flow Reserve
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Icahn School of Medicine at Mount Sinai

Title: Optical Coherence Tomography Predictors of 
Functionally Significant Side Branch Compromise after 
Provisional Main Vessel Stenting in Bifurcation Lesion 
Assessed by Fractional Flow Reserve (ORBID-FFR) 
PI: Annapoorna Kini, MD 
NCT03115580 
Document Date: January 19, 2017  

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
1 
Revised 3/2/16 
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Brief Summary of Research (250-400 words): 
Protocol Title: Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main Vessel Stenting in 
Calcific Coronary Artery Disease (CAD) Assessed by Fractional Flow Reserve 
(ORBID-FFR)  
 
This is a single-center, randomized study in patients with stable coronary artery 
disease. 
1) Objectives: 
Research Question:  
To analyze the incidence of SB compromise after  provisional main vessel stenting in 
calcified bifurcation lesions of CAD patients, determine the incidence and OCT predictors of 
functionally significant SB stenosis defined as FFR ≤ 0.8 and to compare the FFR values with 
3D-OCT measurements of jailed SB ostium after MV stenting. 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
2 
Revised 3/2/16 
 
2) Background 
Coronary artery bifurcation lesion is a common lesion subset in PCI 
accounting for 15-20% of the total number of interventions. Treatment of 
coronary artery bifurcation lesions represents a challenging area in 
interventional cardiology. When compared with non-bifurcation interventions, 
bifurcation interventions have a lower rate of procedural success, higher 
procedural costs, longer hospitalization and a higher clinical and angiographic 
restenosis. Factors contributing to this adverse outcome include limitations of 
angiography in assessment of side-branch (SB) disease severity and the lack 
of established angiographic predictors of SB patency and lumen compromise. 
Better understanding of the underlying plaque morphology and plaque 
composition may facilitate more effective treatment of bifurcation lesions.  
Intravascular imaging has provided new understanding of mechanisms 
associated with SB compromise following bifurcation PCI. Plaque shift has 
been traditionally considered as the principal mechanism for side-branch 
compromise after main vessel intervention.  Rotational atherectomy(RA) has 
been advocated for the treatment of bifurcation lesions, since it can effectively 
remove plaque with minimal injury to adjacent normal arterial segments and 
potentially reduce plaque shifting, the “snow plow” effect.   Intravascular 
ultrasound (IVUS) has been used for guidance in bifurcation lesions, aiding 
the visualization of plaque morphology at the main vessel and the side-
branches and helping the selection of stent size and length as well as the 
selection of stenting strategy. However, due to the low spatial resolution of 
IVUS, all attempts for three-dimensional visualization have only focused on 
visualization of the luminal contour and not on the vessel morphology or the 
vessel-stent interaction. Optical coherence tomography (OCT) has ~10 times 
higher resolution than IVUS, which allows precise evaluation of the 
microstructure of the vessel wall including lipid pool, fibrous cap, 
calcification, and thrombus. OCT has been shown to constitute a valuable tool 
for PCI guidance and also the utility of three-dimensional (3D) renderings for 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
3 
Revised 3/2/16 
assessing the mechanism of side-branch compromise following intervention in 
bifurcation lesions. The recent development of OCT with online 3D 
reconstruction allows the operator to obtain a 3D visualization of the lesion 
and may provide a unique tool for guidance during complex bifurcation PCI 
and potentially improve stenting results. 3D OCT has been used to visualize 
jailed side branches after implantation of bioresorbable scaffolds in the main 
branch and develop a new classification system based on the number of SB 
compartments. In addition, its potential clinical application in guiding the 
rewiring of the distal compartment of the SB ostium (jailed with stent struts 
after MB stenting) to minimize the risk of floating struts was demonstrated It 
is important to note that while OCT, 3D-OCT, and 3D-QCA (such as that used in the 
ORBID trial) are imaging modalities that can be used to answer important research 
questions, their wide-spread adoption in daily clinical practice has been very limited. 
Intravascular ultrasound (IVUS) is used more frequently as part of a PCI guidance 
strategy in daily clinical practice. 
Fractional flow reserve (FFR) is a pressure-derived, lesion specific index used 
to determine the functional significance of coronary artery stenosis. Several 
studies showed that FFR is a safe and feasible method to assess the 
significance of an ostial SB stenosis after provisional stenting. Quantitative 
coronary angiography (QCA) has been shown to be unreliable in assessing the 
functional significance of SB after stent implantation in MV (the area under 
the curve 0.64, 41.5% sensitivity and 83.1% specificity) suggesting that 
treatment decisions for jailed SB should not be based on angiographic 
findings alone. A recent report demonstrated a better ability of post-PCI 3D-
OCT to predict the functional significance for SB ostial lesions caused by a 
jailed SB outcome.   
A previous study (ORBID) of 30 patients was done at Mount Sinai Hospital and aimed 
to identify the predictors of side branch (SB) ostial stenosis developed after provisional 
stenting of the main vessel (MV) using Optical Coherence Tomography (OCT). The 
study Showed that High lipid content of the MV lesion and a contralateral location of 
lipid in the bifurcation area may contribute to SBOS after provisional stenting. 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
4 
Revised 3/2/16 
   
3) Setting of the Human Research 
ICAHN School of Medicine at Mount Sinai and the Mount Sinai Hospital  
GP 5 East Ambulatory Area 
4) Resources Available to Conduct the Human Research 
Given the high-volume of the Mount Sinai catheterization laboratory and its 
dedicated research infrastructure, patient recruitment is unlikely to pose a 
challenge. Mount Sinai serves a large New York City based population with 
extensive referrals from the Tri-State area. This will ensure our ability to 
screen and recruit appropriate patients.  All members of the research team 
delegated to participate in this research protocol are adequately informed 
about the protocol and their trial-related duties and /or functions.  The 
personnel listed on the HRP-211 with their Curriculum Vitae will serve to 
recruit patients to the study and will be adequately informed about the 
protocol; and their trial related duties and functions thru a site initiation visit 
by the sponsor after the IRB approval process; regular monthly/quarterly 
teleconferences and possible sponsor initiated meetings at the site or at 
another location. 
All persons on the research team have completed CITI training, HIPPA 
training as well as all required research training and credentials to perform 
research.  They are informed about the protocol, the investigational 
product(s), and their trial-related duties and functions. 
5) Study Design 
 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
5 
Revised 3/2/16 
 
Figure 1. 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
6 
Revised 3/2/16 
 
Data analysis and Statistical methods: 
T-test will be used. OCT off-line image analysis. For the accurate characterization of 
bifurcation lesions, OCT images will be analyzed systematically at 1 mm intervals 
according to previously validated criteria for plaque characterization using the St. Jude 
Medical Offline Review Workstation as we described previously. In addition, three-
dimensional OCT software (QAngio OCT, Medis) will be used to obtain the information 
for the side branch ostium from a single main branch pullback as described recently in a 
validation of cut plane analysis (Figure 2).  We will also perform three-dimensional 
quantitative coronary angiography (3D-QCA) using QAngio XA 3D software (Medis) to 
obtain the measurements of bifurcation angles, stenosis, and references. This software is 
dedicated to bifurcation lesions and has shown to provide highly accurate assessment of 
lesion dimensions and geometry based on 3D reconstruction of bifurcation lesions. 
Offline analysis of side branch for impingement of the ostium of SB leading to acute loss 
in SB diameter, area, carina shift and plaque shift will be performed and 3D-OCT 
parameters will be correlated with SB FFR measurements. 
 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
7 
Revised 3/2/16 
 
Figure 2. 3D quantitative coronary angiography (QCA) and cut-plane analysis of side branch 
ostium from the main branch OCT pullback for bifurcation PCI before (top row) and after 
(bottom row) stenting. 
 
We assumed FFR (+) prevalence of either 20% or 25% based on previous studies.   We 
also assumed that there would be a roughly equal proportion of patients with high and 
lipid levels. 
 
Based on these assumptions, we will need at least 75 patients per EACH high lipid and 
low lipid groups to detect an odds ratio (OR) of 2.8. 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
8 
Revised 3/2/16 
 
The table below is showing the detectable OR we might have under different assumptions 
of the patient population assuming an equal proportion of high/low lipid level groups. 
 
Prevalence of + FFR 
Patients per group 
Detectable OR with 80% power 
0.2 
50 
3.7 
0.2 
75 
2.9 
0.2 
100 
2.5 
0.25 
50 
3.5 
0.25 
75 
2.8 
0.25 
100 
2.4 
 
a) Recruitment Methods 
We will recruit patients referred to the interventional cardiologists 
involved on this study based on their medical history who require a PCI of 
the main vessel with drug eluting stent implantation for the treatment of 
stable CAD where impact on the side branch can be access. Patients will 
be undergoing a PCI using an angiography and OCT-guided strategy. 
Patients will be approached in the ambulatory unit before their procedure 
to obtain consent and review and confirm the inclusion and exclusion 
criteria of the protocol. 
The PI and the research team will identify potential subjects based on their 
medical history. Potential patients will be approached in the ambulatory 
unit before their procedure to obtain consent and check the 
inclusion/exclusion criteria. 
In all cases, the Principal Investigator, Sub-Investigator or member of the 
Research Team will discuss the research trial and informed consent 
document in full detail following Good Clinical Practices and HIPAA 
Laws. During the informed consent process, all of the potential subject’s 
questions will be answered. Subjects will be given a copy of the signed 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
9 
Revised 3/2/16 
informed consent document, a copy will be placed in the subject’s chart 
and the original copy will be stored in a secure location in the research 
office. 
b) Inclusion and Exclusion Criteria 
1. General inclusion criteria. Subjects will be enrolled in the study, if ALL of the 
following criteria are met 
 
• All patients over 18 years of age presenting with stable coronary artery disease.   
• Patients must have a clinical indication for coronary intervention.   
• Creatinine Kinase Myocardial-Band Isoenzyme (CK-MB) must be less than or 
equal to the upper limit of lab normal (ULN) value within eight hours prior to 
the procedure 
 
2. Angiographic inclusion criteria. Subjects will be enrolled in the study, if ALL 
of the following criteria are met: 
• The target lesion must be a de novo calcified bifurcation coronary lesion that 
hasn’t been previously treated with any interventional procedure for which 
provisional main vessel stenting strategy is planned after reviewing angiogram. 
• The target vessel must be a native coronary artery with  
a) stenosis ≥70% and <100%, or 
b) Stenosis ≥50% and <70% with evidence of clinical ischemia via 
positive stress test, or FFR ≤ 0.8, or IVUS or OCT minimal lumen 
area ≤ 4.0 mm2. 
• The target lesion should have SB DS 30 - 70%.  
• The target main vessel reference diameter must be ≥2.5 mm and ≤ 4.0 mm. 
• The SB reference diameter must be > 2 mm by coronary angiogram. 
• The target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow 
grade 3 at baseline. 
 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
10 
Revised 3/2/16 
General exclusion criteria: Patient will not be enrolled in the study if ANY of the 
following criteria are present in the patient. 
 
• 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) 
c) Number of Subjects 
One hundred and fifty (150) consecutive patients with lesions requiring 
PCI of main vessel with drug eluting stent implantation for the treatment 
of stable CAD will be included in the study. 
d) Study Timelines 
This is a randomized study with one visit and no clinical follow-ups. 
e) Study Endpoints 
The primary endpoint is SB compromise defined as SB DS > 70%, or dissection 
or TIMI < 3. 
The secondary endpoints  
• SB FFR after main vessel stenting and its correlation with OCT imaging 
parameters before PCI 
• OCT predictors of SB TIMI flow reduction after main vessel PCI 
• Off-line analysis of SB stenosis by 3D-OCT and its correlation with FFR; 
correlation between 3D-QCA measurements, 3D-OCT, and FFR data.  

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
11 
Revised 3/2/16 
• Association between calcification assessment by angiography and OCT 
imaging. 
• FFR Device Success (ability to successfully deliver FFR wire to desired 
SB distal   segment [n/150]). 
• FFR Wire Workhorse Capability (proportion of patients [n/150] in which 
FFR wire able to serve as rail to deliver additional interventional devices 
to target SB lesion). 
 
f) Procedures Involved in the Human Research 
Stable CAD patients with bifurcation lesions in whom provisional stenting 
strategy is planned, who have moderate or severe calcification in the main 
vessel lesion identified by angiography, SB stenosis 30-70% and SB 
reference diameter > 2mm will be enrolled in the study. 
Moderate calcification will be defined as radiopaque density observed 
only during the cardiac cycle and typically involving only one side of the 
vascular wall, and severe calcification will be defined as radiopaque 
density noted without cardiac motion prior to contrast injection and 
involving both sides of the arterial wall.  After completion of diagnostic 
angiogram and confirmation of subject eligibility, subjects will be 
randomly assigned to Rotational atherectomy (RA or Cutting Balloon 
Angioplasty (CBA)/PTCA group in a 1:1 fashion. 
Patients in both groups will undergo PCI with stent implantation according to 
current standards of care. Lesion preparation including lesion pre-dilation, scoring 
or sculpting balloon angioplasty, and use of atherectomy and protection devices 
will be performed at the operator’s discretion, followed by MV stenting. The 
operator will also decide in both groups about the length and size of the implanted 
stent. Procedural optimization, such as post-dilation or additional stent 
implantation will be performed based only on the angiographic findings, 
according to the discretion of the operator.  

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
12 
Revised 3/2/16 
 
Optical coherence tomography (OCT) is an established medical imaging 
technique that uses light to capture micrometer-resolution, three-
dimensional images from within optical scattering media will be 
performed to analyze plaque morphology, the extent and location of 
calcification, side branch size, angle, and ostial involvement. 
Patients in both groups will undergo (standard of care) a percutaneous 
coronary intervention (PCI), also known as coronary angioplasty, is a 
nonsurgical technique for treating obstructive coronary artery disease, 
including unstable angina, acute myocardial infarction (MI), and 
multivessel coronary artery disease (CAD) with stent implantation 
according to current standards of care. Lesion preparation including lesion 
pre-dilation, scoring or sculpting balloon angioplasty, and use of 
atherectomy (a minimally invasive endovascular surgery technique for 
removing atherosclerosis from blood vessels within the body.) and 
protection devices will be performed at the operator’s discretion, followed 
by MV stenting.  
The operator will also decide in both groups about the length and size of 
the implanted stent. Procedural optimization, such as post-dilation or 
additional stent implantation will be performed based only on the 
angiographic findings, according to the discretion of the operator.  
The Pre and post stenting OCT + FFR for side branch are the research procedures. 
OCT pullback will be performed after lesion preparation before stenting 
(OCT-PRE) and after PCI (OCT-POST). FFR measurement in the side 
branch will be performed, if the coronary angiogram shows SB DS < 70%, 
TIMI grade 3 flow and no dissection in the side branch.  
To perform FFR measurements, the pressure wire will be passed through 
the struts of the MV stent into the SB and FFR will be measured at least 5 
mm distal to the jailed SB stenosis. Adenosine will be infused through the 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
13 
Revised 3/2/16 
femoral vein at least 140 μg/kg per minute to induce maximal coronary 
blood flow.   
g) Specimen Banking 
Not Applicable 
h) Data Management and Confidentiality 
Confidentiality of subject medical information will be ensured by 
providing unique identifiers (Subject ID) for data transmitted from the 
enrolling centers to St. Jude Medical Center. Designated representatives 
will not receive identifiable subject information.  
Subject ID is a unique identifier and automatically generated in the 
database upon completing the baseline/enrollment electronic case report 
form (eCRF).  This ID cannot be re-identified to a patient.  The only 
identifying information is that data which has been entered on the eCRF. 
Data generated, including Subject ID’s, for the study will be stored in a 
limited-access file area located in KCC Room 678 and be accessible only 
to representatives at the study site, St. Jude Medical Center and its 
representatives and FDA/relevant health authorities/regulatory agencies. 
Limited-access file area is a secure shared drive, which only research 
personnel have access to. Source documents for subjects consented and 
subsequently enrolled will be maintained in locked cabinets within the 
research office. Office access is limited to research personnel. 
All required data for this trial will be collected via electronic case report 
forms (eCRF) and securely transferred by a 21 CFR Part 11 compliant 
electronic data capture (EDC) system 
 
i) Provisions to Monitor the Data to Ensure the Safety of subjects 
Part I: Elements of a Data and Safety Monitoring Plan 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
14 
Revised 3/2/16 
MSSM Principal Monitor:  Principal Investigator  
 Last Name:  Kini 
First Name: Annapoorna  
Academic Title: Professor of Medicine/Cardiology 
Department: Medicine/ Cardiology/CVI 
Mailing Address: Box 1030, One Gustave L. Levy Place, NY, NY, 10029  
Phone: (212) 241-4181 
E-mail: annapoorna.kini@mountsinai.org 
The principal monitor for this trial will be the PI since he is responsible for 
reporting to the IRB and Sponsor all AE/SAE. Investigators are 
responsible for monitoring the safety of subjects who have entered this 
study and for alerting the IRB and FDA to any event that seems unusual, 
even if this event may be considered an unanticipated benefit to the 
subject.  
The investigator is responsible for the appropriate medical care of the 
subjects during the study.  
The investigator remains responsible for following, through an appropriate 
health care option, adverse events that are serious or that caused a subject 
to discontinue before completing the study. The subject should be 
followed until the event is resolved or explained.  
It is the Investigator’s responsibility to classify the relationship of an 
adverse event as definite, Probable, possible, unlikely or not related on the 
Adverse Event eCRF.   
 
j) Withdrawal of Subjects 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
15 
Revised 3/2/16 
All subjects should be encouraged to remain in the study through the 
duration of the follow-up period; however, if a subject decides to 
discontinue study participation, the reason for discontinuation must be 
recorded in the medical record and submitted via the electronic Case 
Report Form (eCRF). Subjects who discontinue participation prematurely 
will be included in the analysis of results (as appropriate) but they will not 
be replaced in the enrollment of total study subjects nor will those subjects 
continue to be followed by research personnel. Information previously 
collected on such subjects may be reviewed and monitored by research 
personnel and sponsoring agency to ensure compliance with protocol and 
data accuracy.  
6) Risks to Subjects 
Risks to subjects enrolled in this study include risks to subject privacy and 
release of protected health information (PHI). The study team plans to protect 
your confidentiality. Their plans for keeping your information private are 
described in the 'confidentiality' section of this consent form. 
OCT and FFR are widely used in every day clinical practice. Any procedure’s related 
adverse event will be recorded, evaluated and reported. The procedure films will be 
reviewed by the PI and the imaging team after the procedure for data analysis and 
effectiveness purposes.  
This research study includes exposure to radiation from x-rays or gamma rays.  This 
radiation exposure is for research purposes only and is in addition to any radiation 
needed for your medical care. X-rays and gamma rays from natural or medical 
sources can damage the genetic material (DNA) in your cells. At low doses, the body 
is usually able to repair the damage.  Radiation risk is believed to be related to the 
total lifetime exposure. You should think about your own history of radiation 
exposure from tests (like x-rays or CT scans) in deciding about the radiation in this 
study.  If you have questions about the total amount of radiation you will be 
receiving, you should ask your doctor. 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
16 
Revised 3/2/16 
 
The estimated radiation exposure that subjects will get for this research study will be 
10.37mSv (an mSv is a unit of absorbed radiation). The greatest annual exposure 
(10.37 mSv) is projected to be in year(s) 1. This exceeds the 6.2 mSv that the average 
person in the United States gets each year from both natural sources like the sun, 
outer space, air, food and soil, as well as from medical procedures.  It is less than the 
50 mSv of radiation that is allowed each year for people who are exposed to radiation 
in their jobs. 
 
Angiogram and angioplasty (using stent to open the blockage) will be done as 
standard of care. Use of this type of device is known to be associated with the 
following risks: 
• 
Coronary or stent thrombosis (when a blood clot forms on the surface of a stent) 
• 
Increased vascular and/or bleeding complications (due to a problem with 
blood clotting). 
• 
Arrhythmia (irregular heart beat) 
• 
Blood vessel rupture, which may result in a build-up of fluid around the heart  
• 
Increased length of hospital stay 
• 
Infection due to contamination of the stent, which may lead to thrombosis 
(blood clot inside a vessel), pseudoaneurysm (leaking blood from an artery), 
or vessel rupture (bursting). 
• 
Spasm, thrombosis (blood clot), and/or distal embolization (obstruction) 
caused by implantation of the stent; stent could migrate from the site of 
implantation  
• 
Rupture and life-threatening bleeding caused by excessive stretching of the artery 
• 
Partial deployment (incomplete placement) of stents in particularly resistant 
 
lesions 
• 
Stent dislodgment and/or migration from the target site during or after 
implantation    
 
 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
17 
Revised 3/2/16 
7) Provisions for Research Related Injury 
In the event of injury resulting from your participation in this research study, 
the facilities at Mount Sinai Hospital and professional attention will be made 
available to you at your expense.  Financial compensation from Mount Sinai 
will not be provided.  If you believe that you have suffered an injury related to 
this research as a participant in this study, you should contact Dr. Annapoorna 
Kini at telephone number (212) 241-4181. 
8) Potential Benefits to Subjects 
 
Not Applicable. 
9) Provisions to Protect the Privacy Interests of Subjects 
All potential subjects are subjects are referred by their private physicians and 
are patients undergoing Cardiac Catherization procedures and subsequent PCI 
by an interventional cardiologist in the Mount Sinai Cardiac Catherization 
Laboratory.  The private physician will be asked if a patient may be 
approached by a member of the study team. 
Potential subjects who come to MSH the day of the procedure, or are in-
patients at MSH will be approached in the unit, pre-catheterization unit or in 
their assigned room of the patient care unit.  Only personnel directly involved 
with the study (investigators and research coordinators) will approach subjects 
for consent. It is acceptable and appropriate for members of the research team 
to approach prospective participants because all members of the research team 
delegated to participate in this research protocol are adequately informed 
about the protocol and their trial-related duties and /or functions.  
Potential subjects will be approached for consent before the catheterization 
procedure. The ambulatory unit and the pre-catheterization unit are in the 
Cardiac Catheterization procedural preparation area. As is the case for in-
patient subjects, all patients are provided with a private hospital bed for 
procedural preparation. We will make all efforts to give an adequate time to 
the subjects and subject’s family to understand the trial and read the consent 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
18 
Revised 3/2/16 
form.  The use of the ambulatory and pre-catheterization cath. lab areas and/or 
the subject’s assigned room in the patient care unit during the consenting 
process is ideal because each subject will have a bed in a private location to 
discuss the details of the trial. The consenting process will always be obtained 
in these private locations. 
This location will be an area different from the actual procedure room in 
which the potential subject can consider the consent as an autonomous 
individual, free from time constraints or a sense of obligation or dependency. 
Patients meeting the inclusion criteria will be informed of the trial details. 
This includes the protocol procedures, risk, benefits, alternative to participate, 
cost of procedure and follow ups, compensation, voluntary participation and 
privacy, etc. The patient will be encouraged to ask questions and all questions 
will be answered to his/her satisfaction. The patients’ responsibility to keep 
the scheduled follow-ups will also be discussed. At this location, the patient 
will be given an adequate amount of time to review the consent document, 
discuss it with whomever they like, digest the information that has been 
presented to them without any element of coercion or being in any kind of 
anxiety provoking situation as to whether they wish to participate and make an 
informed decision, sign the informed consent and HIPAA consent. 
10) 
Economic Impact on Subjects 
Since a PCI procedure is the standard of care that subjects would be 
receiving even if they were not participating in this study, subjects will be 
expected to pay any copayments and insurance deductibles normally 
required by their insurance. This will be true for any standard follow up 
care that subjects receive throughout the clinical trial. Subjects will not 
absorb the extra cost of any procedure that is not part of their routine 
medical care due to their participation in this study. Some insurers have 
specific guidelines associated with clinical trial participation and do not 
pay for treatment provided as part of clinical research. 
11) 
Payment to Subjects 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
19 
Revised 3/2/16 
Not Applicable. 
12) 
Consent Process 
All potential subjects will sign a separate Mount Sinai surgical/procedure 
informed consent for their Cardiac Catherization procedure on the day of 
their hospital visit. On the day of their procedure, and prior to signing the 
informed consent document, the subject’s continued eligibility for the 
study will be reviewed. If the subject does not meet all general 
inclusion/exclusion criteria at this time, they will not be approached, 
consented and/or enrolled in the research trial.  
Consent will be obtained prior to any screening procedures 
After the subject has been determined to be eligible for the research trial, 
legally effective informed consent will be obtained from the patient.  
Recruiters (PIs, Sub-Investigators and Research Staff Members) will be 
following and will adhere to “SOP HRP-090 Informed Consent Process 
for Research” and “SOP HRP-091 Written Documentation of Consent"   
   
Non-English Speaking Subjects:  
Non-English speaking persons will be eligible for consent and subsequent 
enrollment once a PPHS/IRB approved consent document in the potential 
subject’s native language is available for use.  Non-English speaking 
patients will be approached for consent by the study PI, Sub-investigator 
or member of the Research Team that speaks the native language of the 
potential subject and can provide appropriate informed consent. The 
consenting process, timing and setting are the same as for English 
speaking subjects. 
Several members of the research team are fluent in Spanish and would be 
available for the Spanish speaking subjects.  In the future, if the situation 
warrants it, we may utilize an interpreter. 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
20 
Revised 3/2/16 
13) 
Process to Document Consent in Writing 
Subjects will sign a separate Mount Sinai surgical/procedure informed 
consent for the PCI procedure.  
The standard PPHS consent template will be used in this trial. 
Recruiters (PIs, Sub-Investigators and Research Staff Members) will be 
following and will adhere to “SOP HRP-091 Written Documentation of 
Consent"   
14) 
Vulnerable Populations 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. 
infants, children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
 
X 
Pregnant women 
 
X 
Prisoners 
 
15) 
Multi-Site Human Research (Coordinating Center) 
Not Applicable 
16) 
Community-Based Participatory Research 
Not Applicable 
17) 
Sharing of Results with Subjects 

 
Protocol Title: 
Optical Coherence Tomography Predictors of Functionally 
Significant Side Branch Compromise after Provisional Main 
Vessel Stenting In Bifurcation Lesions Assessed by 
Fractional Flow Reserve (ORBID – FFR) 
Principal Investigator 
Name/Contact Info:  
Annapoorna Kini, M.D./ 241-4181/ 
annapoorna.kini@mountsinai.org 
 
Primary Contact 
Name/Contact Info 
Mary Ann Kiernan /241-7634 / 
maryann.kiernan@mountsinai.org 
Yashira Henriquez /241-0564 
yashira.henriquez@mountsinai.org 
 
Date Revised: 
 January 19, 2017 
Study Number: 
HSM# 16-00041/ GCO#1: 16-0204(0001)  
 
21 
Revised 3/2/16 
Not Applicable 
18) 
IRB Review History 
Not Applicable 
19) 
Control of Drugs, Biologics, or Devices 
Note: The IDS has its own forms that must be completed and a review process 
that must be followed before the IDS representative will sign off on Appendix B 
for submission to the PPHS. 
Not Applicable.