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NCT Number: NCT03111940

The Oxford Optimisation of PCI Study (OXOPT-PCI 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.

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Key information

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford University Hospital - NHS Trust

Oxford, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimisation of the result of intracoronary stenting according to specific algorithm

Procedure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of Participants With Stent-edge Dissection Assessed by OCT

    Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure

    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

  2. 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

    Defined as reference lumen area <4.5 mm2, with significant residual plaque within 10 mm of stent edges

  3. Number of Participants With Stent Malapposition Assessed by OCT

    Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure

    Defined as stent-adjacent vessel lumen distance > 200 μm

  4. Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT

    Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure

    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

  5. Number of Participants With Stent Under-expansion Assessed by OCT

    Time frame: During PCI procedure, OCT typically adds 5 minutes to the procedure

    Defined as minimal stent area (MSA) < 70% of average reference lumen area and/or MSA < 4.5 mm2

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Acronym: OXOPT-PCI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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