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

NCT03111940 | Completed Results

• 1 other identifier: 12005
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants With Stent-edge Dissection Assessed by OCT

  During PCI procedure, OCT typically adds 5 minutes to the procedure

• Number of Participants With Reference Lumen Narrowing (Geographical Miss) Assessed by OCT

  During PCI procedure, OCT typically adds 5 minutes to the procedure

• Number of Participants With Stent Malapposition Assessed by OCT

  During PCI procedure, OCT typically adds 5 minutes to the procedure

• Number of Participants With Plaque/Thrombus Protrusion Assessed by OCT

  During PCI procedure, OCT typically adds 5 minutes to the procedure

• Number of Participants With Stent Under-expansion Assessed by OCT

  During PCI procedure, OCT typically adds 5 minutes to the procedure

Study Arms (2)

PCI optimisation

EXPERIMENTAL

Post PCI FFR below 0.9

Procedure: Optimisation of the result of intracoronary stenting according to specific algorithm

No PCI optimisation

NO INTERVENTION

Post PCI FFR 0.9 or higher

Interventions

Optimisation of the result of intracoronary stenting according to specific algorithm PROCEDURE

PCI optimisation

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford University Hospital - NHS Trust

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof Adrian Banning
• Organization: Oxford Heart Centre, John Radcliffe Hospital

Adrian.Banning@ouh.nhs.uk

01865 228934

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: April 13, 2017
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Locations

GB (1)