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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Optimisation of the result of intracoronary stenting according to specific algorithm

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Oxford University Hospital - NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PCI optimisation; Post PCI FFR below 0.9	Procedure: Optimisation of the result of intracoronary stenting according to specific algorithm
NO_INTERVENTION: No PCI optimisation; Post PCI FFR 0.9 or higher

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 12005 (DAIDS-ES Registry)