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NCT number NCT03259815
Study type Interventional
Source NHS National Waiting Times Centre Board
Contact Keith G Oldroyd, MB, MD
Phone 00441419515180
Email keith.oldroyd@nhs.net
Status Not yet recruiting
Phase N/A
Start date September 4, 2017
Completion date June 30, 2019

Clinical Trial Summary

There has recently been renewed interest in the measurement of post percutaneous coronary intervention (PCI) Fractional Flow Reserve (FFR). Previous studies have suggested that post PCI FFR values ≥ 0.90 are associated with better clinical outcomes for patients but the available data suggest that despite angiographically satisfactory results, this is actually achieved in less than 40% of cases.

The main mechanisms for sub-optimal post PCI FFR measurements have been proposed to be stent underexpansion, unmasking of a second lesion in the target vessel post PCI, residual diffuse disease in the untreated segments and pressure drift (a technical artifact of pressure wire technology).

Using post PCI FFR to guide stent optimisation and/or further intervention in the target vessel has been shown to increase the frequency of achieving optimal post PCI FFR results (and therefore presumably better clinical outcomes). However, there are additional costs involved in the routine use of post PCI FFR and it is not clear just how often it is even possible to increase the initial post PCI FFR to ≥ 0.90. This uncertainty means that it is currently difficult to either recommend the routine use of post PCI FFR or justify its cost.

The investigators propose a prospective study to assess the feasibility of achieving post PCI FFR ≥ 0.90 during standard PCI procedures in consecutive patients. The study would also attempt to elucidate the mechanisms for sub-optimal FFR results when they occur. The investigators anticipate using the data from this developmental study to support a subsequent funding application for a definitive phase 3 study of the impact of FFR targeted PCI on clinical outcomes.


Clinical Trial Description

Original hypothesis

A simple Physiologically-guided Incremental Optimisation Strategy (PIOS) can increase the proportion of patients undergoing PCI in whom a post PCI FFR ≥0.90 can be achieved from 40% to 60%.

Experimental details and design of proposed investigation

Overall aim:

A randomised control trial of a physiologically-guided optimisation strategy to determine the feasibility of increasing the proportion of post PCI FFR measurements ≥ 0.90 in a consecutive series of patients undergoing standard PCI procedures.

Study Population:

260 consecutive patients with stable angina referred for invasive management to the cardiac catheterisation lab who have been selected to undergo PCI based on either angiographic appearances or prior FFR assessment. Patients will be caffeine free for >12 hours pre-procedure.

Methods/Design:

Informed consent will be obtained prior to cardiac catheterisation in all potential subjects conforming to the inclusion and exclusion criteria.

Patients will then be randomised to one of two groups (described below) and PCI will be performed, using a pressure guidewire, according to standard practice at the Golden Jubilee National Hospital (including lesion pre-dilation and post-dilation of the stented segment).

Group 1 (PIOS Group):

Operator-blinded FFR will be measured post PCI. If FFR is ≥ 0.90, no further intervention will be performed and the procedure is considered complete.

If FFR is < 0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback during either a standard peripheral intravenous adenosine infusion (140mcg/kg/min) or an intracoronary adenosine infusion (360mcg/min) via a microcatheter will be performed. Depending on the result the operator would then have the following options:

A. If there is a step-up of ≥ 0.05 across the stented segment(s) further post-dilatation with a 0.25 - 0.50mm larger non-compliant balloon to at least 18 atmospheres should be performed followed by repeat FFR. Alternatively, the operator may choose to employ intracoronary imaging (IVUS or OCT) to guide post-dilation/optimisation of the stented segment.

B. If there is a step-up of ≥ 0.05 across a relatively focal (<20mm) unstented segment which is technically suitable for further stenting then a further stent should be implanted followed by repeat FFR.

C. If the FFR remains < 0.90 after steps A +/- B, a further FFR pullback will be performed. If the criteria for Step B are again met, one additional stent may be deployed and a final FFR pullback performed. Following this, the FFR result will be accepted.

D. If the residual pressure gradient is interpreted to reflect diffuse atherosclerosis with no focal step-ups, the result is accepted.

E. At the end of the procedure the pressure wire sensor will be withdrawn to the tip of the guiding catheter and compared with the aortic pressure. A pressure drift of ≤ 0.03 will be accepted and the final FFR result adjusted accordingly.

F. If there is a drift of ≥ 0.04, the wire should be re-equalised and the final FFR measurement be repeated.

G. The patients will have their demographics and procedure details recorded. All patients will receive 3-month telephone follow-up.

Group 2 (Control Group):

Post PCI FFR will be recorded but not disclosed to the operator. The angiographically defined result will be accepted. The patients will have their demographics and procedure details recorded. All patients will receive 3-month telephone follow-up.

Expected value of results

1. Confirmation that the proposed PIOS protocol significantly increases the proportion of patients obtaining a physiologically optimal post PCI result will demonstrate the feasibility of this strategy and should lead to an increase in post PCI pressure wire usage to achieve physiologically optimal results for patients.

The investigators hypothesise that the PIOS intervention can increase the proportion of patients achieving this target from 40% to 60% and believe that an increment of at least this magnitude would be necessary to make a future larger study with both patient-oriented clinical (target vessel failure) and health care system (resource utilisation) outcomes acceptable to the interventional cardiology community and potential funders.

2. The secondary outcome measures, albeit underpowered for clinical outcomes in this study, will hopefully still give a signal that achieving a target post PCI FFR ≥ 0.90 does yield objective benefits for patients. This could then form the basis for a larger phase 3 trial to confirm improved clinical outcomes and cost- effectiveness of FFR targeted PCI


Study Design


Related Conditions & MeSH terms


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