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NCT05896501Completed

Role of FFR in ACS Patients: Pressure ACS Registry

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
501 (actual)
First submitted
31 May 2023
Start date
1 Jan 2020
Primary completion date
31 Dec 2025
Lead sponsor
The Catholic University of Korea
NCT number
NCT05896501

What you commit to

  • Study type: Observational
  • Participants enrolled: 501
  • From 1 Jan 2020 to the primary completion date, 31 Dec 2025
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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

Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Daejeon St.Mary's Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status
Incheon St.Mary's Hospital
Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
St. Vincent's Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaUnknown status
Uijeongbu ST. Mary's Hospital
Coordinator of this site? Confirm its status
Uijeongbu-siSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.