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Active, Not Recruiting

NCT Number: NCT05896501

Role of FFR in ACS Patients: Pressure ACS Registry

Currently, fractional flow reserve (FFR) is regarded as a gold-standard invasive method to define lesion-specific ischemia and FFR-guided PCI has been proven to reduce unnecessary revascularization and to enhance patient's clinical outcomes. Therefore, current guidelines recommend FFR measurement for intermediate coronary stenosis when there is no definite evidence of lesion-specific ischemia. However, previous evidences which well demonstrated the benefit of FFR-guided strategy were mostly generated from patients with stable coronary artery disease.4 FFR may be overestimated and the hemodynamic relevance of a coronary stenosis underestimated in patients with acute coronary syndrome (ACS).Its role in ACS patients still needs to be defined although several studies have recently published addressing the value of FFR-guided PCI in ACS. In fact, recent evidence suggests that culprit lesions of patients presenting with a non-ST-segment elevation myocardial infarction that were deferred based on a "negative" FFR have a relatively high event rate, calling into question the use of FFR in that patient population.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St.Vincent's Hospital, Suwon, Gyeonggido, South Korea

Loading trial locations.

About this study

STUDY OBJECTIVE

  • To evaluate the impact of FFR on decision for PCI in ACS patients
  • To assess the long term prognosis of deferring PCI based on FFR value in non-culprit lesion; defying the cut-off value of FFR for PCI in the non-culprit lesion of ACS patients
  • To identify the relation between OCT findings and FFR value in culprit and non-culprit lesions of ACS patients
  • To compare the long term prognosis of PCI or deferring PCI based on FFR value in non-culprit lesion of ACS patients
  • To identify OCT findings to predict the lesion progression in deferred lesions.
  • To assess the long term prognosis of post-PCI FFR value in the culprit lesion of NSTE-ACS patients
  • To assess the efficacy of routine use of FFR to guide PCI in ACS patients; angiographically guidance versus FFR guidance

Who can participate

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

Inclusion criteria

  • Subject age 19-85 years old
  • Diagnosed as ACS (unstable angina/ Non ST elevation myocardial infarction, ST elevation myocardial infarction)
  • At least one stenosis of >50% in a non-culprit vessel ≥ 2.0 mm by visual estimation with TIMI 3 - multivessel disease after PCI for culprit lesion or single vessel disease with ambiguity for PCI ④ FFR within hospitalization for index PCI for ACS

Exclusion criteria

  • Severe stenosis with TIMI flow ≤ II of the non-IRA artery
  • Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus
  • Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)

⑤ Pregnancy or breast feeding

⑥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).

⑦ Other primary valvular disease with severe degree: severe mitral regurgitation or mitral stenosis, severe aortic regurgitation or aortic stenosis

⑧ Patients with a history of Coronary Artery Bypass Graft(CABG)

⑨ Unwillingness or inability to comply with the procedures described in this protocol.

Treatment and study plan

Fractional flow reserve

Device

Functional assessement of anatomical stenosis of coronary artery

Primary outcomes

  1. Rate of Major adverse cardiac events

    Time frame: 24 months

    Rate of the composite of all-cause death, recurrent myocardial infarction

Secondary outcomes

  1. Rate of Major adverse cardiac events at 1 year

    Time frame: 12 months

    Rate of composite of all-cause death, recurrent myocardial infarction

  2. Rate of Ischemic events

    Time frame: 24 months

    Rate of the composite of all-cause death, recurrent myocardial infarction, and any repeat revascularization

  3. Rate of Death

    Time frame: 24 months

    Rate of All cause death and cardiac death

  4. Rate of Repeat revascularization

    Time frame: 24 months

    Rate of Any repeat revascularization

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Role of Fractional Flow Reserve Assessment Using Pressure Wire in Patients With Acute Coronary Syndrome Who Treated With Xience Stent; a Multicenter, Prospective, and Observational Registry

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Oct 2, 2024

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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