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

NCT ID: NCT03111940

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-07-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI optimisation

Post PCI FFR below 0.9

Group Type: EXPERIMENTAL

Optimisation of the result of intracoronary stenting according to specific algorithm

Intervention Type: PROCEDURE

No PCI optimisation

Post PCI FFR 0.9 or higher

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Optimisation of the result of intracoronary stenting according to specific algorithm

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Adrian Banning

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oxford University Hospital - NHS Trust

Oxford, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

12005

Identifier Type: -

Identifier Source: org_study_id