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An Evaluation of a Physiology-guided PCI Optimisation Strategy (Target-FFR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259815
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : August 15, 2019
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 suboptimal stent deployment, unmasking of a second lesion in the target vessel post PCI, residual diffuse disease in the untreated segments and pressure drift (a technical artefact 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

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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 : November 2019
Estimated Study Completion Date : March 2020

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 will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min).

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. The proportion of patients with a final post-PCI FFR result ≥0.90 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI FFR result ≥0.90 will be compared between the randomised groups


Secondary Outcome Measures :
  1. The proportion of patients with final post-PCI FFR ≤0.80 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI FFR result ≤0.80 will be compared between the randomised groups

  2. 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

  3. 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

  4. 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.

  5. The rate of target vessel failure (TVF) and its component features at 1 year. [ Time Frame: 1 year ]
    Component features of TVF include cardiac death, myocardial infarction, stent thrombosis, unplanned rehospitalisation with target vessel revascularisation.

  6. Change from baseline in the FFR following PCI [ Time Frame: 1 day ]
    The difference between measurements of Fractional Flow Reserve taken in the target vessel pre- and post-PCI

  7. The proportion of patients with final post-PCI dPR ≥0.90 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI Diastolic Pressure Ratio (dPR) value ≥0.90

  8. Change from baseline in the Diastolic Pressure Ratio (dPR) following PCI [ Time Frame: 1 day ]
    The difference between measurements of the Diastolic Pressure Ratio taken in the target vessel pre and post PCI

  9. The proportion of patients with final post-PCI RFR ≥0.90 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI Resting Full-cycle Ratio (RFR) value ≥0.90

  10. Change from baseline in the Resting Full-Cycle Ratio (RFR) following PCI [ Time Frame: 1 day ]
    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 in TTrest following PCI [ Time Frame: 1 day ]
    Change of the thermodilution-derived resting transit time (TTrest) from pre-PCI to final post-PCI value

  12. Change in TThyp following PCI [ Time Frame: 1 day ]
    Change of the thermodilution-derived hyperaemic transit time (TThyp) from pre-PCI to final post-PCI value

  13. The proportion of patients with final post-PCI CFR value ≥2.0 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI Coronary Flow Reserve (CFR) result ≥2.0

  14. Change from baseline in the Coronary Flow Reserve (CFR) following PCI [ Time Frame: 1 day ]
    The difference between measurements of Coronary Flow Reserve taken in the target vessel pre and post PCI

  15. The proportion of patients with final post-PCI IMR >25 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI Index of Microcirculatory Resistance (IMR) value >25

  16. Change from baseline in the Index of Microcirculatory Resistance (IMR) following PCI [ Time Frame: 1 day ]
    The difference between measurements of IMR taken in the target vessel pre and post PCI

  17. The proportion of patients with final post-PCI IMRc >25 [ Time Frame: 1 day ]
    The proportion of patients with a final post-PCI corrected Index of Microcirculatory Resistance (IMRc) value >25

  18. Procedure Duration [ Time Frame: 1 day ]
    The time required to perform the PIOS intervention procedures will be compared with those in the control group.

  19. The cost of additional equipment employed in the experimental arm [ Time Frame: 1 day ]
    The cost of additional equipment employed in the PIOS intervention (i.e. balloons/stents/intra-coronary imaging).

  20. Fluoroscopy Dose [ Time Frame: 1 day ]
    The radiation doses for the PIOS intervention procedures will be compared with those in the control group.

  21. Contrast Material Dose [ Time Frame: 1 day ]
    The contrast material doses for the PIOS intervention procedures will be compared with those in the control group.

  22. Incidence of procedural complications such as coronary artery dissection or perforation. [ Time Frame: 1 day ]
    The incidence of procedural complications such as coronary artery dissection or perforation will be recorded and compared between the two study arms


Other Outcome Measures:
  1. 'As Treated' analysis of the proportion of patients with a final post-PCI FFR result ≥0.90 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  2. 'As Treated' analysis of the proportion of patients with final post-PCI FFR ≤0.80 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  3. 'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the Seattle Angina Questionnaire (SAQ) [ Time Frame: 3 months ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  4. 'As Treated' analysis of the change from baseline in self-reported health outcomes at 3 months as assessed by the EQ-5D questionnaire. [ Time Frame: 3 months ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  5. 'As Treated' analysis of the rate of target vessel failure (TVF) and its component features at 3 months. [ Time Frame: 3 months ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  6. 'As Treated' analysis of the rate of target vessel failure (TVF) and its component features at 1 year. [ Time Frame: 1 year ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  7. 'As Treated' analysis of the change from baseline in the FFR following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  8. 'As Treated' analysis of the proportion of patients with final post-PCI dPR ≥0.90 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  9. 'As Treated' analysis of the change from baseline in the dPR following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  10. 'As Treated' analysis of the proportion of patients with final post-PCI RFR ≥0.90 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  11. 'As Treated' analysis of the change from baseline in the RFR following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  12. 'As Treated' analysis of the change in TTrest following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  13. 'As Treated' analysis of the change in TThyp following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  14. 'As Treated' analysis of the proportion of patients with final post-PCI CFR value ≥2.0 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  15. 'As Treated' analysis of the change from baseline in the CFR following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  16. 'As Treated' analysis of the proportion of patients with final post-PCI IMR >25 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  17. 'As Treated' analysis of the change from baseline in the IMR following PCI [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.


  18. 'As Treated' analysis of the proportion of patients with final post-PCI IMRc >25 [ Time Frame: 1 day ]

    The primary efficacy analyses of the study intervention will be carried according to the 'intention to treat' principle (i.e. results will be compared between randomised groups according to the pre-specified outcome measures).

    An 'As Treated' analysis will also be performed as an additional outcome measure. This will compare patients who actually received the PIOS intervention with those who did not.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • PCI to an in-stent restenosis (ISR) lesion
  • PCI to a target artery providing Rentrop grade 2 or 3 collateral blood supply to another vessel
  • 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
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Contact: Keith G Oldroyd, MB, MD 00441419515180 keith.oldroyd@nhs.net

Locations
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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
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Principal Investigator: Keith G Oldroyd, MB, MD NHS National Waiting Times Centre Board
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Keith G. Oldroyd, Principal Investigator, NHS National Waiting Times Centre Board
ClinicalTrials.gov Identifier: NCT03259815    
Other Study ID Numbers: 17/CARD/10
IRAS ID 223780 ( Other Identifier: Health Research Authority )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Physiology-guided PCI Optimisation
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases