The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Oxford University Hospitals NHS Trust

 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
Page: 
1 of 31 
 
Study Title: Multimodal Assessment to Optimise the Result of Percutaneous 
Coronary Interventions.  
 
Short title: The Oxford Optimisation of PCI Study (OXOPT-PCI study). 
 
              
 
Chief Investigator: 
  Prof. Adrian Banning, Consultant Cardiologist 1 
Investigators:  
Prof. Rajesh Kharbanda, Consultant Cardiologist 1 
Dr. Jeremy Langrish, Consultant Cardiologist 1 
Dr. Andrew Lucking, Consultant Cardiologist 1 
Dr. Mathias Wolfrum, Interventional Research Fellow 1 
Dr. Giovanni Luigi De Maria, Interventional Research Fellow 2 
1 Oxford University Hospitals NHS Foundation Trust 
2 University of Oxford 
 
Sponsor:  
Oxford University Hospitals NHS Foundation Trust 
 
Funder: 
Department of Cardiovascular Medicine 
 
  
Chief Investigator Signature/Date:  
 
No potential conflicts of interest to declare 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other 
than the Sponsor, the Investigator Team, host organisation, and members of the Research 
Ethics Committee, unless authorised to do so. 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
Page: 
2 of 31 
 
 
TABLE OF CONTENTS 
1. 
AMENDMENT HISTORY .................................................................................................. 4 
2. 
KEY TRIAL CONTACTS ................................................................................................... 4 
3. 
SYNOPSIS ........................................................................................................................ 4 
4. 
ABBREVIATIONS ............................................................................................................. 6 
5. 
BACKGROUND AND RATIONALE .................................................................................. 7 
5.1 
Post-PCI FFR as an indicator of clinical outcome ....................................................... 7 
5.2 
Causes of persistently low FFR after PCI ................................................................... 7 
5.3 
Assessment of coronary physiology (coronary pressure/flow) .................................... 8 
5.4 
Imaging Modalities Used to Evaluate Coronary Artery Disease ................................. 8 
5.5 
Background Summary ................................................................................................. 9 
5.6 
Study Hypothesis ........................................................................................................ 9 
6. 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS .......................................... 10 
7. 
TRIAL DESIGN ............................................................................................................... 11 
8. 
STUDY RISKS AND BENEFITS ..................................................................................... 12 
8.1 
Study risks ................................................................................................................. 12 
8.1.1 
Standard PCI procedure ......................................................................................... 12 
8.1.2 
Cardiac physiological measurements .................................................................... 13 
8.1.3 
Intravascular imaging ............................................................................................. 13 
8.2 
Study benefits ............................................................................................................ 13 
9. 
PARTICIPANT IDENTIFICATION ................................................................................... 13 
9.1 
Study Participants ..................................................................................................... 13 
9.2 
Inclusion Criteria ........................................................................................................ 14 
9.3 
Exclusion Criteria ...................................................................................................... 14 
10. STUDY PROCEDURES ................................................................................................ 15 
10.1 
Study timeline (see “Integrated flowchart for OXOPT-PCI study” as in Appendix 1)
 
15 
10.2 
Recruitment ............................................................................................................. 15 
10.3 
Consent ................................................................................................................... 15 
10.3.1 Screening and Final Eligibility Assessment ............................................................ 15 
10.3.2 Informed Consent ................................................................................................... 15 
10.4 
Baseline Visit ........................................................................................................... 16 
10.5 
Study visit - Intervention: Coronary angiogram and PCI ......................................... 16 
10.5.1 Stage 1: Diagnostic Coronary Angiogram and FFR Assessment .......................... 18 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
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3 of 31 
 
10.5.2 Stage 2: Stenting .................................................................................................... 18 
10.5.3 Stage 3: Assessment and Optimisation of PCI Result ........................................... 18 
10.5.4 Stage 4: Assessment of the PCI Optimisation ....................................................... 19 
10.5.5 Stage 5: Optimisation of the PCI Result according to FFR/ End of Procedure ...... 19 
10.6 
Post PCI Assessment and Discharge Management ............................................... 20 
10.7 
Follow up visit - Telephone follow-up at 12 months ................................................ 21 
10.8 
Discontinuation/Withdrawal of Participants from Study ........................................... 21 
10.9 
Definition of End of Study ........................................................................................ 21 
11. STUDY ASSESSMENTS ............................................................................................... 23 
11.1 
Clinical Data Collection ........................................................................................... 23 
11.2 
Analysis of cardiac physiological measurements .................................................... 23 
11.3 
Optical Coherence Tomography (OCT) .................................................................. 23 
12. SAFETY Reporting ........................................................................................................ 23 
12.1 
Definitions of Serious Adverse Events .................................................................... 23 
12.2 
Reporting Procedures for Serious Adverse Events ................................................. 24 
13. STATISTICS .................................................................................................................. 25 
13.1 
Number of Participants ............................................................................................ 25 
13.2 
Analysis of Endpoints .............................................................................................. 25 
14. DATA MANAGEMENT ................................................................................................... 26 
14.1 
Access to Data ........................................................................................................ 26 
14.2 
Data Recording and Record Keeping ..................................................................... 26 
15. Quality assurance procedures ....................................................................................... 26 
16. ETHICAL AND REGULATORY CONSIDERATIONS .................................................... 26 
16.1 
Declaration of Helsinki ............................................................................................. 26 
16.2 
Guidelines for Good Clinical Practice ...................................................................... 27 
16.3 
Approvals ................................................................................................................ 27 
16.4 
Reporting ................................................................................................................. 27 
16.5 
Participant Confidentiality ........................................................................................ 27 
17. Funding and INSURANCE ............................................................................................. 27 
17.1 
Funding ................................................................................................................... 27 
17.2 
Insurance ................................................................................................................. 27 
18. PUBLICATION POLICY ................................................................................................. 28 
19. REFERENCES .............................................................................................................. 29 
20. Appendix ........................................................................................................................ 31 
20.1 Appendix A: Integrated Flowchart for the OxOPT - PCI study ....................................... 31 
 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
Page: 
4 of 31 
 
1. 
AMENDMENT HISTORY 
Protocol version no. 
Effective 
Date 
Significant Changes 
Previous 
protocol version 
no. 
1.1 
25.07.2016 
Primary outcome measure re-
defined. Revision of chapter 13. 
Clarification on the patient identifier. 
(changes made as requested by the 
Ethics Committee 
1.0 
1.2 
14.09.2016 
2 Investigators added 
1.1 
 
 
 
 
 
 
 
 
 
2. 
KEY TRIAL CONTACTS 
 
Chief Investigator 
Prof Adrian P. Banning 
Department of Cardiology 
John Radcliffe Hospital 
Headington, Oxford, OX39DU 
Adrian.Banning@ouh.nhs.uk 
Tel:  01865 228934  
Fax: 01865 220585 
Sponsor 
Oxford University Hospitals NHS Foundation Trust 
Research and Development Department 
Joint Research Office 
Block 60, Churchill Hospital 
Headington 
Oxford OX3 7LE 
E-mail: ouh.sponsorship@nhs.net 
  Fax: 01865572242 
 
3. 
SYNOPSIS 
Study Title 
Multimodal Assessment to Optimise the Result of Percutaneous 
Coronary Interventions. The OXOPT-PCI study 
Study Design 
Prospective single centre clinical trial 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
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Short Title: 
OXOPT-PCI study 
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Study Participants 
Pts aged 30-90 presenting for coronary angiography and PCI 
Number of 
Participants 
100 
Treatment duration 
Maximum of 30 minutes  
Follow up duration 
12 months 
Planned Study 
Period 
1 year 
Primary Objective 
To assess the impact of a study specific treatment algorithm on final 
FFR after PCI measured in the target vessel. 
Secondary 
Objectives 
The OXOPT-PCI study aims to assess the frequency of intracoronary 
pathologies after PCI that potentially lead to an impaired FFR using 
OCT according to CLI-OPCI II study criteria. 
Tertiary Objectives 
1. To assess the impact of a study specific treatment algorithm on final 
parameters of coronary physiology after PCI measured in the target 
vessel. 
2. To assess the impact on clinical outcome.  
Intervention (s) 
Optimisation of PCI result according to a study specific algorithm 
 
 
 
 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
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Short Title: 
OXOPT-PCI study 
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4. 
ABBREVIATIONS 
  
BMS 
Bare metal stent 
CFR 
Coronary flow reserve 
CI 
Chief Investigator 
DES 
Drug eluting stent 
FFR 
Fractional flow reserve 
GCP 
Good Clinical Practice 
IC 
Informed Consent 
ICF 
Informed Consent Form 
IMR 
Index of microcirculatory resistance 
MACE 
Major adverse cardiac events 
OCT 
Optical coherence tomography 
PCI 
Percutaneous coronary intervention 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
POBA 
Plain old balloon angioplasty 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 
 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
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Short Title: 
OXOPT-PCI study 
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5. 
BACKGROUND AND RATIONALE 
 
Fractional flow reserve (FFR) is the established gold standard used in the cardiac 
catheterisation laboratory to assess the haemodynamic relevance of coronary artery 
stenoses before stenting. Evidence from various clinical scenarios has shown that an FFR-
guided PCI strategy reduces the need for stenting and improves clinical outcomes. 
Therefore, FFR has been incorporated in current revascularisation guidelines. 1-3 
 
Visual assessment of the interventional result by angiography and quantitative coronary 
angiography (QCA), has limited efficacy with respect to identifying patients with suboptimal 
PCI results and subsequent worse clinical outcomes.4, 5 Post-PCI FFR measurement has 
been shown to be a useful indicator for the identification of a suboptimal PCI result in small 
observational studies using older techniques including plain old balloon angioplasty (POBA), 
bare metal stents (BMS) and first/ second generation drug eluting stents (DES). 
 
5.1 Post-PCI FFR as an indicator of clinical outcome 
In 1999, Bech et al. demonstrated that FFR was useful for stratifying patient outcome after 
plain old balloon angioplasty (POBA).7 Receiver operating characteristics (ROC) curve 
analysis identified a post-POBA FFR of 0.89 as optimal predictor for worse clinical outcome 
at two years follow up (MACE rate: 40.6 vs. 11.5%; area under curve (AUC) = 0.69). 
This was subsequently confirmed for PCI using bare metal stents. Pijls et al. showed that 
FFR after BMS implantation was an independent predictor of clinical outcome at 6 months.6  
In this study patients with a post-stent FFR <0.9 had a significantly worse outcome after 6 
months than those with an FFR ≥0.9 (MACE rate: 20.3 vs. 5.5%). Analysing data for state of 
the art technologies showed that the FFR following implantation of drug-eluting stents (DES) 
predicted MACE at one year in a study reported in 2011.7 Receiver operating characteristics 
(ROC) curve analysis identified an FFR <0.90 as optimal predictor for worse outcome at one-
year follow up (MACE rate: 12.5 vs. 2.5%, ROC analysis: sensitivity = 67%, specificity = 
58%, AUC = 0.69, 95% CI = 0.53–0.86). 
5.2 Causes of persistently low FFR after PCI 
Retrospective studies using intra-coronary imaging have identified possible underlying 
causes for a suboptimal FFR, including incomplete stent expansion, stent malapposition, 
“geographical miss”, plaque protrusion, edge dissection, and plaque shift at the stent edge. 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
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Short Title: 
OXOPT-PCI study 
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(Figure 1). 
 
 
Figure 1. Potential causes of suboptimal FFR after percutaneous coronary interventions. Panel A: ‘geographical miss’ 
(diseased reference segment). Panel B: stent mal-apposition. Panel C: stent under-expansion. Panel D: intrastent plaque-
protrusion/thrombus. Panel E: edge dissection. MLA - minimal lumen area, REF - proximal reference segment. 
 
5.3 Assessment of coronary physiology (coronary pressure/flow) 
Coronary flow and pressure measurements are widely recognised to determine the degree of 
disease for epicardial vessels and for the microcirculation.8 The pressure wire is 
interchangeable with the coronary guide wire used in all PCI procedures, so is incorporated 
in to the procedure. Measurements that assess the integrity of the small blood vessels of the 
heart are made at the end of the PCI in response to administration of clinically used drugs 
such as adenosine to increase coronary flow. Saline is flushed through the guide catheter to 
measure coronary flow using the transit time calculation. Incorporating these parameters are 
recognised to support the clinical decision making but no standardized guidelines for their 
application after stenting has been established. 
5.4 Imaging Modalities Used to Evaluate Coronary Artery Disease 
5.4.1 Optical coherence tomography (OCT)  

 
 
 
Subject: 
Research Protocol 
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Principal Investigator: 
Adrian Banning 
Version/Date: 
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OXOPT-PCI study 
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OCT is a high resolution intravascular imaging modality that can accurately characterise 
coronary morphology.9  Recently a study evaluating the relationship between final stent 
dimensions, determined by optical coherence tomography (OCT), post-stent FFR, and 
clinical outcome the intrastent area stenosis (AS) was positively correlated with post-stent 
FFR (r2 = 0.49; P < 0.001), and both parameters were good predictors of MACE rate at 20-
month follow up.10 The optimal thresholds to predict MACE was 0.905 for post-stent FFR, 
based on ROC analysis (sensitivity 71.4%, specificity 85.0%, AUC 0.77, 95% CI 0.56–0.97).  
 
5.5 Background Summary 
Based on available evidence a persistently low FFR following PCI is associated with an 
adverse clinical outcome. Small observational studies using intra-coronary imaging have 
suggested different underlying causes for a suboptimal FFR. The aim of this prospective 
clinical trial is to confirm that these are the responsible mechanisms and to examine whether 
additional simple procedures can influence post-stent FFR and potentially improve clinical 
outcome. 
 
5.6 Study Hypothesis 
1) A post PCI FFR < 0.9 is linked to a suboptimal stent deployment. 2) Using a dedicated 
algorithm incorporation FFR measurements and intracoronary imaging will improve 
interventional result.  
 
 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
Page: 
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6. 
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
 
Objectives 
Outcome Measures/Endpoints  
Primary Objective 
To assess the impact of a dedicated 
treatment algorithm on final FFR after PCI 
measured in the target vessel.  
Proportion of patients with FFR >0.9 at 
baseline versus proportion of patient with 
FFR measured at the end of optimisation 
procedure (final FFR) 
Secondary Objectives 
The OXOPT-PCI study aims to assess the 
frequency of intracoronary pathologies after 
PCI that potentially lead to an impaired FFR 
using OCT according to CLI-OPCI II study 
criteria.  
 
1. Frequency of: 
- 
Stent-edge dissection 
- 
Geographical miss/Reference lumen 
narrowing 
- 
Stent-malapposition 
- 
In-stent minimum lumen area (MLA) < 
4.5 mm2 
- 
In-stent MLA <70% of the average 
reference lumen area 
- 
Intrastent plaque/thrombus protrusion 
2. Frequency of a significant pressure step 
up during pressure wire pullback during 
maximal hyperaemia.  
Tertiary Objectives 
1. To assess the impact of a dedicated 
treatment algorithm on final parameters of 
coronary physiology after PCI measured in 
the target vessel. 
2. To assess the impact on clinical outcome.  
1. Coronary flow reserve (CFR), index of 
microcirculatory resistance (IMR) measured 
at the end of PCI. 
2. Composite of death, myocardial infarction 
and target vessel revascularisation after 12 
months of follow up. 
 
 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
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Short Title: 
OXOPT-PCI study 
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7. 
TRIAL DESIGN 
The OXOPT-PCI study is a prospective single centre clinical trial investigating the use of a 
dedicated, study specific treatment algorithm on the final result of PCI in patients with 
suspected or known coronary artery disease, including acute myocardial infarction (except 
for ST elevation myocardial infarction), who present for coronary angiography with the usual 
expectation of proceeding to PCI.  
 
Patients, age 30-90, will be included in the study. Informed consent will be obtained prior to 
the angiography/ PCI procedure. 
 
A flowchart of the study design, indicating the time points and procedures, is shown in 
Appendix A. 
 All PCI procedures, coronary imaging and coronary physiology measurements will be 
performed in a standard fashion. A specific treatment algorithm incorporating parameters of 
coronary imaging and coronary physiology will dictate further optimisation of the stent result 
(Figure 2, Chapter 10.5.). After stenting all patients will undergo intravascular imaging with 
OCT and in all patients the FFR will be assessed in the stented vessel. The initial stent result 
will be optimised based on intravascular imaging if clinically indicated by the CLI-OPCI II 
study criteria (see chapter 10.5.3). Following optimisation of the stent result the OCT 
assessment and the FFR measurement in the target vessel will be repeated. At this stage 
the study population will be divided into two groups according to the latter FFR recording.  
 
Group A includes patients with an FFR value <0.9. In these patients the OCT images will be 
used to decide according to the CLI-OPCI II criteria whether and how to optimise the stent 
result (see chapter 10.5.5). If further optimisation was carried out the intervention will be 
concluded by repeated assessment of coronary physiology (FFR, CFR, IMR) and 
intravascular imaging. If no further stent-optimisation was performed the intervention will be 
concluded by the assessment of CFR and IMR.  
 
Group B includes all patients with an FFR ≥0.9. As this FFR value can be considered 
satisfactory, no further optimisation of the interventional result will be attempted and the PCI 
will be concluded by the assessment of CFR and IMR. Procedural details including details of 
the PCI, the coronary physiology measurements and intravascular imaging studies (OCT-
studies) at all stages of the study and of all study patients will be recorded. The total 
procedure and PCI/ OCT/ coronary physiology study times will be also collected. Post-PCI 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
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assessment and discharge strategy will be carried out according to routine clinical practice. 
Telephone follow-ups will be then  
performed at 12 months to assess current symptoms and cardiovascular events. The end of 
the study for each patient will be the date of the 12 months telephone follow-up.  
 
This is a clinical trial in attempt to give some insights regarding the utility of a specific multi-
modal algorithm to improve the result of PCI. In view of the absence of data on this topic, it 
has been designed as pilot study for power analysis and sample size calculation of a further 
main study.11 Based on this assumption it was designed as a non-randomised clinical trial. 
 
Comments from an external peer review have been considered when finalising this protocol. 
8. 
STUDY RISKS AND BENEFITS 
8.1 Study risks 
8.1.1 
Standard PCI procedure 
The patients taking part in this study will undergo a standard percutaneous coronary 
intervention with stenting on the basis of clinical reasons.  
 
Standard risks associated with a PCI procedure include:  
- bruising in the groin, which are usually self-limiting, occur in 1 in 10-20 people; 
- femoral vascular injury requiring a minor surgical repair occurs in 1 in 200 people; 
- TIA or stroke occurs approximately 1 in 300 people; 
- cardiac perforation requiring a drain at the time of the operation occurs in 1 in 500 people;  
- emergent surgery occurs approximately 1 in 500 people; 
- fatal complication (death in the catheter laboratory) is estimated to be 1 in 2000 people; 
- cancer secondary to fluoroscopy exposure during the PCI procedure is negligible 
considering the average low radiation dose and the short fluoroscopy time used. 
 
When compared with the PCI protocol currently used in our centre, the current clinical trial 
protocol differs only with respect to routine use of cardiac physiological measurements and 
the routine use of intravascular imaging (OCT) according to a dedicated algorithm after 
stenting. Optimisation of the PCI result will be carried out only if clinically indicated by FFR or 
OCT findings, which is in line with current routine practise. Final assessment of IMR and 
CFR after stenting are not part of routine practice and special attention will be paid to 
minimize radiation and use of contrast agent. 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
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13 of 31 
 
 
8.1.2 
Cardiac physiological measurements 
Coronary pressure wire studies are routinely performed during PCI procedures. Based on 
local audit data, the average radiation exposure for a patient during routine angiography is 5 
mSv. The additional IMR/CFR measurement adds on average only 1.6 mSv to the 
procedure. Wire associated adverse effects (e.g. coronary dissection) are to be expected in 
1 in 500 to 1000 cases. This is in the range of the expected rate of adverse events using a 
standard guide wire. 
 
8.1.3 
Intravascular imaging 
Intravascular imaging using OCT is often performed during PCI to assist in the procedure. 
This current study will use OCT as indicated by the study specific algorithm. The OCT 
procedure itself is done in standard manner. The utilization of these modalities typically adds 
up to 5 minutes to the procedure duration. Use of any intra-coronary device such as OCT 
device can cause ischaemia, chest discomfort or, rarely, other local coronary complications 
during the PCI (1 in 500 cases). However, this is in the context of a PCI procedure where 
significant interventions such as balloon expansion and stent deployment are already being 
carried out in the coronary artery, which themselves may cause ischaemia, chest pain that 
may require the use of analgesia, or other local coronary complications. 
 
8.2 Study benefits 
Optimisation of the PCI according to a dedicated algorithm gaining information from coronary 
pressure/flow measurements and intravascular imaging is useful to the interventional 
cardiologist in optimising the PCI strategy. Based on current literature potential benefits 
include a reduction in repeated myocardial infarction and target lesion revascularisation.  
 
9. 
PARTICIPANT IDENTIFICATION 
9.1 Study Participants 
Participants aged 30-90 referred for either non-emergency or emergency diagnostic coronary 
angiography (except for ST elevation myocardial infarction) on the basis of known or 
suspected coronary artery disease, with the intention to proceed to PCI where clinically 
indicated.   

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
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Short Title: 
OXOPT-PCI study 
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9.2 Inclusion Criteria  
 
Participants must satisfy the following conditions: 
- 
Participant is willing and able to give informed consent for participation in the study 
- 
Male or Female, aged 30 to 90 years,  
- 
angiogram shows haemodynamically relevant lesion suitable for PCI and suitable for the 
use of intravascular imaging (OCT) 
9.3 Exclusion Criteria 
The participant may not enter the study if ANY of the following are known to apply: 
- 
Patients in whom safety or clinical concerns preclude participation.  
- 
ST elevation myocardial infarction 
- 
Anaemia (Hb <9) 
- 
pregnancy, trying for a baby or breast feeding 
- 
Revascularization by mean of balloon angioplasty without stenting 
- 
Known severe renal failure (eGFR < 30 ml/min/1.73m2) or history of dialysis or renal 
transplant 
- 
Presentation with cardiogenic shock 
- 
Unconscious on presentation 
- 
Contraindications to adenosine 
 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
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10. STUDY PROCEDURES 
10.1 Study timeline (see “Integrated flowchart for OXOPT-PCI study” as in Appendix 1) 
10.2 Recruitment 
Participants will be identified by the clinical care team from pre-angiogram clinic or 
angiogram procedure waiting lists. They will be posted or given an invitation letter and 
information leaflet with reply slip, either with their appointment letter or whilst awaiting the 
PCI procedure as an inpatient. If patients are willing to participate, they may return the reply 
slip and/or inform the clinical care team at their consultation who will then inform study 
investigators. Inpatients will have a minimum of 24 hours to consider their participation in this 
study. 
 
Based on the annual audit data ~1500 PCI are performed at the JR Hospital (~30 per week). 
Of these 30 cases at least > 50% would fulfil the inclusion criteria of the present study. 
These numbers justify the feasibility of the suggested 100 participants over the time of 1 
year. 
 
10.3 Consent 
10.3.1 
Screening and Final Eligibility Assessment 
The following details will be addressed taking into account the patients’ medical history and 
screening the patients’ medical notes:  
a. demographics; 
b. exclusion of exclusion criteria 
c. detailed collection of any relevant medical history 
d. list of current medications 
10.3.2 
Informed Consent 
Informed consent (IC) will be obtained by a qualified and experienced investigator who is 
familiar with the study protocol and procedures. This may be the Chief Investigator (CI), a 
Key Investigator, the research fellow or a research nurse. The list of eligible individuals will 
be specified in the delegation log.  
Written versions of the Participant Information and Informed Consent (IC) will be presented 
to the participants detailing no less than: the exact nature of the study; what it will involve for 
the participant; the implications and constraints of the study and the benefits and risks 

 
 
 
Subject: 
Research Protocol 
Ethics Ref/ IRAS number: 
16/SC/0394/ 204681 
Principal Investigator: 
Adrian Banning 
Version/Date: 
V1.2_14.09.2016 
Short Title: 
OXOPT-PCI study 
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involved in taking part. It will be clearly stated that the participant is free to withdraw from the 
study at any time without giving a reason or any prejudice to future care and rights.  
 
Written IC will then be obtained by means of participant dated signature and dated signature 
of the person who presented and obtained the IC. This will be undertaken before the 
baseline visit commences. A copy of the signed ICF will be given to the participants and one 
copy will be added to the patients’ medical notes. The original signed form will be retained at 
the study site. The participant must personally sign and date the latest approved version of 
the informed consent form before any study specific procedures are performed. 
 
10.4  Baseline Visit 
In addition to the screening and final eligibility assessment before the consent the patients’ 
medical notes and medical history will be taken on the day of the study visit. 
 
10.5  Study visit - Intervention: Coronary angiogram and PCI 
All PCI procedures, coronary imaging and coronary physiology measurements will be 
performed in a standard fashion. A specific treatment algorithm incorporating parameters of 
coronary imaging and coronary physiology will dictate further optimisation of the stent result  
(Figure 2).