The Oxford Optimisation of PCI Study (OXOPT-PCI Study)

Study Overview
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Brief Summary
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The OxOPT-PCI study addresses patients with coronary artery disease who are referred to the John Radcliffe Hospital because of the need for treatment with an intra-coronary stent (metal scaffold) for clinical reasons. Although, this has become a highly standardised procedure it is still challenging for the clinician to assess the final success of this procedure at the end of intervention with conventional methods. This shortcoming can potentially translate into a worse clinical outcome for approximately 10 percent of all patients treated with an intra-coronary stent for this type of disease. This study (OxOPT-PCI) investigates if the use of blood flow measurements (namely measurement of fractional flow reserve (FFR)) and intravascular imaging (namely optical coherence tomography (OCT)) after the implantation of a stent can improve the treatment result for these patients. Both, FFR and OCT are being used already in daily clinical routing but their usefulness especially in combination is not clear. In order to standardise the optimisation procedure we developed a specific algorithm to make sure that all patients receive the same optimisation measures based on the assessment of FFR and OCT. The benefit of this specific optimisation algorithm will be assessed by measuring 1) indices of coronary blood flow, 2) intravascular imaging at the end of the procedure, and 3) by contacting the patients 12 months after stenting to verify the clinical mid-term success.

Official Title
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The Oxford Optimisation of PCI Study (OXOPT-PCI Study)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Optimisation of the result of intracoronary stenting according to specific algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participant is willing and able to give informed consent for participation in the study angiogram shows haemodynamically relevant lesion suitable for PCI and suitable for the use of intravascular imaging (OCT) Exclusion Criteria: patients in whom safety or clinical concerns preclude participation ST-segment elevation myocardial infarction presentation with cardiogenic shock revascularization by mean of balloon angioplasty without stenting contraindications to adenosine

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI optimisation<br>Post PCI FFR below 0.9 | Procedure: Optimisation of the result of intracoronary stenting according to specific algorithm<br> <br> |
| No Intervention: No PCI optimisation<br>Post PCI FFR 0.9 or higher | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Fractional Flow Reserve (FFR) After Intracoronary Stenting | After administration of intracoronary nitrates, FFR was measured under maximal hyperaemia, using intravenous adenosine (140 mg kg-1 min-1) as the ratio between distal coronary pressure (Pd) and aortic pressure (Pa) | Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stent-edge Dissection Assessed by OCT | Defined as presence of a linear rim of tissue ≥200 μm in width and with clear separation from the vessel wall, or underlying plaque <5 mm from stent edges | During PCI procedure, OCT typically adds 5 minutes to the procedure | 
| Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT | Defined as reference lumen area <4.5 mm2, with significant residual plaque within 10 mm of stent edges | During PCI procedure, OCT typically adds 5 minutes to the procedure | 
| Number of Participants With Stent Malapposition Assessed by OCT | Defined as stent-adjacent vessel lumen distance > 200 μm | During PCI procedure, OCT typically adds 5 minutes to the procedure | 
| Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT | Defined as tissue prolapsing between stent struts extending inside a circular arc connecting adjacent struts or intraluminal mass ≥500 μm thick with no direct connection to the vessel wall, or highly backscattered luminal protrusion in continuity with the vessel wall, resulting in signal-free shadowing | During PCI procedure, OCT typically adds 5 minutes to the procedure | 
| Number of Participants With Stent Under-expansion Assessed by OCT | Defined as minimal stent area (MSA) < 70% of average reference lumen area and/or MSA < 4.5 mm2 | During PCI procedure, OCT typically adds 5 minutes to the procedure |