CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Optimisation of the result of intracoronary stenting according to specific algorithmprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03111940
NCT03111940N/ACompleted

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

Oxford University Hospitals NHS Trust·interventional·Posted Apr 13, 2017·Updated Apr 8, 2021

In Brief

A clinical study evaluating Optimisation of the result of intracoronary stenting according to specific algorithm for Coronary Artery Disease. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartAug 1, 2016
Primary CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.2 years ago

Interventions

Optimisation of the result of intracoronary stenting according to specific algorithmprocedure