Physiologic Assessment of Coronary Stenosis Following PCI

Physiologic Assessment of Coronary Stenosis Following PCI - DEFINE PCI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45522

Enrollment

Registered

2017-10-26

Start date

2018-12-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blockage in heart artery coronary stenosis

Interventions

coronary stenosis

post-PCI iFR

Eligibility

Age

18 Years to 64 Years

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Rate of residual ischemia defined as iFR	—

Secondary

Measure	Time frame
Secondary clinical endpoints: 1. 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 defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization 3. Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1year 4. All-cause and cardiac mortality at one year 5. Target vessel Myocardial infarction at one year 6. Ischemia-driven target vessel revascularization at one year 7. Recurrent ischemia at one-year Secondary physiology endpoints: 8. Correlation between iFR 50% assessed by visual interpretation 9. 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 of the cause for impaired iFR (categorized as stent related, distant focal stenosis, or diffuse atherosclerosis) 11. Predictors of delta iFR before and after PCI	—

Measure

Time frame

Secondary clinical endpoints: 1. 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 defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization 3. Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1year 4. All-cause and cardiac mortality at one year 5. Target vessel Myocardial infarction at one year 6. Ischemia-driven target vessel revascularization at one year 7. Recurrent ischemia at one-year Secondary physiology endpoints: 8. Correlation between iFR 50% assessed by visual interpretation 9. 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 of the cause for impaired iFR (categorized as stent related, distant focal stenosis, or diffuse atherosclerosis) 11. Predictors of delta iFR before and after PCI

—

Countries

Netherlands, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)