Clinical trial NCT03111940: The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
Official title: The Oxford Optimisation of PCI Study (OXOPT-PCI Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Final Fractional Flow Reserve (FFR) After Intracoronary Stenting
timeFrame: Immediately post-stenting for Group 1A and 1B, and post FFR/OCT-guided optimisation for Group 1A
Secondary outcomes:
measure: Number of Participants With Stent-edge Dissection Assessed by OCT
timeFrame: During PCI procedure, OCT typically adds 5 minutes to the procedure
measure: Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT
timeFrame: During PCI procedure, OCT typically adds 5 minutes to the procedure
measure: Number of Participants With Stent Malapposition Assessed by OCT
timeFrame: During PCI procedure, OCT typically adds 5 minutes to the procedure
measure: Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT
timeFrame: During PCI procedure, OCT typically adds 5 minutes to the procedure
measure: Number of Participants With Stent Under-expansion Assessed by OCT
timeFrame: During PCI procedure, OCT typically adds 5 minutes to the procedure
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospital - NHS Trust
Study officials:
References: