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Physiologic Assessment of Coronary Stenosis Following PCI (DEFINE PCI)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084367
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Collaborators:
Duke Clinical Research Institute
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
Volcano Corporation

Brief Summary:
This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).

Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Stenosis Angina, Unstable Angina, Stable Diagnostic Test: iFR pullback

Detailed Description:
DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : January 18, 2019
Actual Study Completion Date : February 18, 2020

Group/Cohort Intervention/treatment
iFR post angiographically successful PCI Diagnostic Test: iFR pullback
iFR pullback assessment post angiographically successful PCI




Primary Outcome Measures :
  1. Number of Participants With Residual Ischemia (iFR <0.90) [ Time Frame: end of procedure/intervention ]
    Residual ischemia is defined as iFR measurement <0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis <50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR<0.90) after a PCI that appeared to be successful based on angiography.


Secondary Outcome Measures :
  1. Cardiac Events [ Time Frame: 12 months ]
    Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI

  2. Target Vessel Failure [ Time Frame: 12 months ]
    Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization

  3. Quality of Life Change From Baseline to 12 Months Follow-up [ Time Frame: 12 months ]

    Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months).

    Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score.

    Outcome is the change in score from baseline to 12 months follow-up.


  4. Cardiac Mortality [ Time Frame: 12 months ]
    All-cause and cardiac mortality at one year

  5. Target Vessel MI [ Time Frame: 12 month ]
    Target vessel Myocardial infarction at one year

  6. Target Vessel Revascularization [ Time Frame: 12 month ]
    Ischemia-driven target vessel revascularization at one year

  7. Recurrent Ischemia [ Time Frame: 12 month ]
    Recurrent ischemia at one-year

  8. Correlation Between iFR and Angiographic Visual Interpretation [ Time Frame: at the end of the procedure/intervention ]

    Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual interpretation.

    This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject.

    An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography.

    Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR <0.90 and coronary stenosis >50% assessed by visual interpretation the correlation is 1).


  9. Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI [ Time Frame: Procedural ]
    Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI

  10. Differentiation [ Time Frame: End of procedure /intervention ]
    Differentiation of the cause for impaired iFR

  11. Delta iFR [ Time Frame: at the end of the procedure/intervention ]
    Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be <0.90. An OR > 1 means greater odds that the post-PCI iFR is <0.90, OR = 1 means there is no association, and OR < 1 means there is a lower odds that the post-PCI iFR is <0.90.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consented subjects with CAD who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation
Criteria

Inclusion Criteria:

  1. Subject must be > 18 years old
  2. Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)
  3. Single vessel CAD with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm OR multi-vessel CAD, defined as at least 2 vessels with ≥40% stenosis
  4. Pre-PCI iFR performed in all vessels intended for PCI
  5. Pre-PCI iFR of <0.90 of at least 1 stenosis
  6. Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion Criteria:

  1. Pregnant or planning to become pregnant for the duration of the study
  2. Acute STEMI (ST-elevated Myocardial Infarction) within the past 7 days
  3. Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump).
  4. Ionotropic or temporary pacing requirement
  5. Sustained ventricular arrhythmias
  6. Prior CABG (Coronary Artery Bypass Graft)
  7. Known ejection fraction ≤30%
  8. Chronic Total Occlusion (CTO)
  9. Known severe mitral or aortic stenosis.
  10. Any known medical comorbidity resulting in life expectancy < 12 months.
  11. Participation in any investigational study that has not yet reached its primary endpoint.
  12. Known severe renal insufficiency (eGFR <30 ml/min/1.72 m2).
  13. TIMI flow <3 at baseline
  14. Intra-coronary thrombus on baseline angiography

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): NCT03084367


Locations
Show Show 28 study locations
Sponsors and Collaborators
Volcano Corporation
Duke Clinical Research Institute
Cardiovascular Research Foundation, New York
Investigators
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Study Director: Becky Inderbitzen, MSE Philips (Volcano)
  Study Documents (Full-Text)

Documents provided by Volcano Corporation:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT03084367    
Other Study ID Numbers: 160101
First Posted: March 20, 2017    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: May 10, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Angina Pectoris
Coronary Stenosis
Angina, Unstable
Angina, Stable
Constriction, Pathologic
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Chest Pain
Pain
Neurologic Manifestations