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How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? (Target-FFR)

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ClinicalTrials.gov Identifier: NCT03259815
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board

Brief 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Stenosis Procedure: P.I.O.S. Diagnostic Test: Pre and post-PCI coronary physiology measurements Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: Single (Care Provider)
Masking Description:

Operator blinded pre and post PCI coronary physiology measurements will be performed in both arms of the study.

Post-PCI FFR results <0.90 in the interventional arm will be disclosed to the operator to allow further intervention

Primary Purpose: Treatment
Official Title: How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? A Randomised Controlled Trial of FFR Targeted PCI (the Target FFR Study)
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: PIOS Intervention Group
Operator-blinded pre and post-PCI coronary physiology measurements will be recorded. 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. The operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result.
Procedure: P.I.O.S.
Physiologically-Guided Incremental Optimisation Strategy

Diagnostic Test: Pre and post-PCI coronary physiology measurements
Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator

Active Comparator: Control Group
Operator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted.
Diagnostic Test: Pre and post-PCI coronary physiology measurements
Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator




Primary Outcome Measures :
  1. An increased proportion of patients with a physiologically optimal result post PCI (FFR ≥ 0.90) [ Time Frame: 2 years ]
    The investigators hypothesise that the PIOS intervention can increase the proportion of patients achieving a post-PCI FFR target of ≥ 0.90 from 40% to 60%


Secondary Outcome Measures :
  1. Change from baseline in self-reported health outcomes at 3 months using a disease-specific quality of life measurement tool. [ Time Frame: 3 months ]
    Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline pre-procedure and again at 3 months post PCI

  2. Change from baseline in self-reported health outcomes at 3 months using a generic quality of life measurement tool. [ Time Frame: 3 months ]
    Patients will complete the EQ-5D questionnaire at baseline pre-procedure and again at 3 months post PCI

  3. The rate of target vessel failure (TVF) and its component features at 3 months. [ Time Frame: 3 months ]
    Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.

  4. Procedure Duration [ Time Frame: 2 years ]
    The time required to perform the PIOS intervention procedures will be compared with those in the control group.

  5. The cost of additional equipment employed in the experimental arm [ Time Frame: 2 years ]
    The cost of additional equipment employed in the PIOS intervention (i.e. balloons/stents/intra-coronary imaging).

  6. Fluoroscopy Dose [ Time Frame: 2 years ]
    The radiation doses for the PIOS intervention procedures will be compared with those in the control group.

  7. Contrast Material Dose [ Time Frame: 2 years ]
    The contrast material doses for the PIOS intervention procedures will be compared with those in the control group.

  8. Incidence of procedural complications such as coronary artery dissection or perforation. [ Time Frame: 2 years ]
    The incidence of procedural complications such as coronary artery dissection or perforation will be recorded and compared between the two study arms

  9. Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI [ Time Frame: 2 years ]
    The difference between measurements of the Diastolic Pressure Ratio taken in the target vessel pre and post PCI

  10. Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI [ Time Frame: 2 years ]
    The difference between measurements of the Resting Full-Cycle Ratio (the lowest Pd/Pa ratio during the whole cardiac cycle at rest) taken in the target vessel pre and post PCI

  11. Change from baseline in the Coronary Flow Reserve (CFR) following PCI [ Time Frame: 2 years ]
    The difference between measurements of Coronary Flow Reserve taken in the target vessel pre and post PCI

  12. Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI [ Time Frame: 2 years ]
    The difference between measurements of IMR taken in the target vessel pre and post PCI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >18 years of age with coronary artery disease (including stable angina and stabilised non-ST-elevation myocardial infarction (NSTEMI)) who are able to provide informed consent.

Exclusion Criteria:

  • PCI in a coronary artery bypass graft
  • Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker).
  • Recent (within 1 week prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion).
  • Severe cardiomyopathy (ejection fraction <30%).
  • Renal insufficiency such that an additional 20 to 30 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259815


Contacts
Contact: Keith G Oldroyd, MB, MD 00441419515180 keith.oldroyd@nhs.net

Locations
United Kingdom
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G81 4DY
Contact: Keith G Oldroyd, MB, MD       keith.oldroyd@nhs.net   
Contact: Damien G Collison, MB       dcollison@nhs.net   
Principal Investigator: Keith Oldroyd, MB, MD         
Sub-Investigator: Colin Berry, MB, PhD         
Sub-Investigator: Damien Collison, MB         
Sponsors and Collaborators
NHS National Waiting Times Centre Board
Investigators
Principal Investigator: Keith G Oldroyd, MB, MD NHS National Waiting Times Centre Board

Responsible Party: Prof. Keith G. Oldroyd, Principal Investigator, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier: NCT03259815     History of Changes
Other Study ID Numbers: IRAS ID 223780
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Keith G. Oldroyd, NHS National Waiting Times Centre Board:
FFR Targeted PCI
Post-PCI FFR

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases