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Completed

NCT Number: NCT03084367

Physiologic Assessment of Coronary Stenosis Following PCI

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).

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AMC Amsterdam, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be > 18 years old
  • Subjects presenting with stable angina, silent ischemia or non-ST-elevation ACS (acute coronary syndrome) (unstable angina or biomarker positive)
  • 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
  • Pre-PCI iFR performed in all vessels intended for PCI
  • Pre-PCI iFR of <0.90 of at least 1 stenosis
  • Subjects are able and willing to comply with scheduled visits and tests and to provide informed consent.

Exclusion criteria

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

Treatment and study plan

iFR pullback

Diagnostic Test

iFR pullback assessment post angiographically successful PCI

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Volcano Corporation

Industry

Collaborators

  • Cardiovascular Research Foundation, New York
  • Duke Clinical Research Institute

Registry information

Official study title

DEFINE PCI: Physiologic Assessment of Coronary Stenosis Following PCI

Acronym: DEFINE PCI

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 20, 2017
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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