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Physiologic Assessment of Coronary Stenosis Following PCI (DEFINE PCI)

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ClinicalTrials.gov Identifier: NCT03084367
Recruitment Status : Active, not recruiting
First Posted : March 20, 2017
Last Update Posted : June 26, 2019
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 pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI.

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

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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
Estimated 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. rate of residual ischemia [ Time Frame: 12 months ]
    Rate of residual ischemia defined as iFR <0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis <50% in any treated lesion in the target vessel)


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

  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 [ Time Frame: 12 months ]
    Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1year

  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: 12 month ]
    Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual interpretation

  9. Focal stenosis [ Time Frame: 12 month ]
    Proportion of cases in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI

  10. Differentiation [ Time Frame: 12 months ]
    Differentiation of the cause for impaired iFR (categorized as stent related, distant focal stenosis, or diffuse atherosclerosis)

  11. delta iFR [ Time Frame: 12 months ]
    Predictors of delta iFR before and after PCI



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 (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 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
  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


  Show 28 Study Locations
Sponsors and Collaborators
Volcano Corporation
Duke Clinical Research Institute
Cardiovascular Research Foundation, New York

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Responsible Party: Volcano Corporation
ClinicalTrials.gov Identifier: NCT03084367     History of Changes
Other Study ID Numbers: 160101
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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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
Signs and Symptoms