Coronary Artery DiseaseOXOPT-PCINCT03111940
The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
A study testing Optimisation of the result of intracoronary stenting according to specific algorithm in people with Coronary Artery Disease, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Optimisation of the result of intracoronary stenting according to specific algorithm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospital - NHS Trust
Oxford, OX3 9DU
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Optimisation of the result of intracoronary stenting according to specific algorithm
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimisation of the result of intracoronary stenting according to specific algorithmProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PCI optimisation | Experimental | Post PCI FFR below 0.9 Receives: Procedure: Optimisation of the result of intracoronary stenting according to specific algorithm |
| No PCI optimisation | No intervention | Post PCI FFR 0.9 or higher |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During PCI procedure, OCT typically adds 5 minutes to the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startAug 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Banning, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111940
- Sponsor's protocol ID
- 12005
- Acronym
- OXOPT-PCI
- Status last verified
- Mar 2021
- First submitted
- 12 Jun 2016
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
- ClinicalTrials.gov ID
- NCT03111940
- Acronym / sponsor ID
- OXOPT-PCI / 12005
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI optimisation | Experimental | Procedure: Optimisation of the result of intracoronary stenting according to specific algorithmPost PCI FFR below 0.9 |
| No PCI optimisation | No intervention | –Post PCI FFR 0.9 or higher |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimisation of the result of intracoronary stenting according to specific algorithm | Procedure or surgery | PCI optimisation |
Primary outcome
Final Fractional Flow Reserve (FFR) After Intracoronary Stenting
Time frame: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A
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)
5 secondary outcomes
Number of Participants With Stent-edge Dissection Assessed by OCT
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
Number of Participants With Stent Malapposition Assessed by OCT
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
Number of Participants With Stent Under-expansion Assessed by OCT
Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimisation of the result of intracoronary stenting according to specific algorithm in people with Coronary Artery Disease, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final Fractional Flow Reserve (FFR) After Intracoronary Stenting (time frame: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.