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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI optimisation | Experimental | Post PCI FFR below 0.9 |
|
| No PCI optimisation | No Intervention | Post PCI FFR 0.9 or higher |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimisation of the result of intracoronary stenting according to specific algorithm | Procedure |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospital - NHS Trust | Oxford | OX3 9DU | United Kingdom |
35 pts recruited
Eligible subjects were referred for elective or urgent complex PCI between September 2016 and July 2017 at the John Radcliffe Hospital, Oxford Heart Centre, United Kingdom. All patients underwent conventional angiography-guided stent deployment, until an acceptable angiographic result was achieved. Following completion of conventional PCI, FFR was measured, and intracoronary OCT imaging was performed. The study population was then divided into two groups based on the observed FFR value.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI | OCT was performed per protocol after achievement of satisfactory angiographic results. OCT was analysed according to the presence of one or more of the following according to CLI-OPCI study criteria: stent underexpansion and/or incomplete lesion coverage and/or stent malapposition and/or stent-edge dissection and/or intra-stent plaque/thrombus protrusion. Operators were mandated to perform PCI optimisation according to the respective OCT finding. |
| FG001 | Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI | No further PCI optimisation was performed and OCT acquisition was performed only as a safety measure, to assess the frequency of relevant vessel-related complications |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Patients With a Suboptimal Functional Result (FFR <0.90) After Conventional PCI | In patients in Group 1, OCT was performed per protocol after achievement of satisfactory angiographic results. OCT was analysed according to the CLI-OPCI study defining a suboptimal stent result according to specific criteria. For patients that fulfilled OCT criteria for optimisation (Group 1A), operators were mandated to perform PCI optimisation according to the respective OCT finding. For patients in Group 1 who did not fulfil the OCT criteria (Group 1B), further PCI optimisation was not performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | OCT-guided PCI optimisation was only performed in Group 1A | Posted | Mean | Standard Deviation | Ratio | Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A |
|
During procedure, approximately 1 hour and 30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PCI Optimisation | Post PCI FFR below 0.9 Optimisation of the result of intracoronary stenting according to specific algorithm |
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Small sample size and non-randomized observational nature limiting statistical power; Larger randomised trials are required to determine clinical impact of any final combined imaging/physiology assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Adrian Banning | Oxford Heart Centre, John Radcliffe Hospital | 01865 228934 | Adrian.Banning@ouh.nhs.uk |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2016 | Mar 4, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| BG001 | Group 2 Patients With a Satisfactory Functional Result (FFR ≥0.90) After Conventional PCI | For patients in Group 2, no further PCI optimisation was performed and OCT acquisition was performed only as a safety measure, to assess the frequency of relevant vessel-related complications. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients from Group 1 who did not fulfil the OCT criteria, and thus, further PCI optimisation was not performed
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | During PCI procedure, OCT typically adds 5 minutes to the procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | During PCI procedure, OCT typically adds 5 minutes to the procedure |
|
|
|
| Secondary | Number of Participants With Stent Malapposition Assessed by OCT | Defined as stent-adjacent vessel lumen distance > 200 μm | Posted | Count of Participants | Participants | During PCI procedure, OCT typically adds 5 minutes to the procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | During PCI procedure, OCT typically adds 5 minutes to the procedure |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | During PCI procedure, OCT typically adds 5 minutes to the procedure |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | No PCI Optimisation | Post PCI FFR 0.9 or higher | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |