Acute Coronary SyndromeNCT05896501
Role of FFR in ACS Patients: Pressure ACS Registry
An observational study of Acute Coronary Syndrome, run by The Catholic University of Korea at 5 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Fractional Flow Reserve
- Type of treatment
- Medical device
- How many people
- 501 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndrome and intermediate stenosis
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Daejeon St.Mary's Hospital
Daejeon
Incheon St.Mary's Hospital
Incheon
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
St.Vincent's Hospital
Suwon, Gyeonggido
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido
About this study
Official 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
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.
Read the detailed description
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
- Conditions
- Acute Coronary Syndrome
- Being tested
- Fractional Flow Reserve
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Flow ReserveDevice
Functional assessement of anatomical stenosis of coronary artery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major adverse cardiac events
Rate of the composite of cardiac death, recurrent myocardial infarction, and repeat revascularization
Measured: 24 months
Secondary outcomes (4)
Rate of Target vessel failure
Rate of the composite of cardiac death, vessel-related myocardial infarction, and target vessel revascularization
Measured: 24 months
Rate of Death
Rate of All cause death and cardiac death
Measured: 24 months
Rate of myocardial infarction
Rate of spontaneous myocardial infarction
Measured: At 24 months
Rate of Repeat revascularization
Rate of Any repeat revascularization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Ho Choo, The Catholic University of Korea
- Investigators
- Eun Ho Choo, M.D.,PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896501
- Sponsor's protocol ID
- PressureACS
- Status last verified
- Oct 2026
- First submitted
- 31 May 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05896501
- Acronym / sponsor ID
- PressureACS
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndrome and intermediate stenosis
Key inclusion criteria (3 listed)
- Subject age 19-85 years old
Key exclusion criteria (9 listed)
- Severe stenosis with TIMI flow ≤ II of the non-IRA artery
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Flow ReserveFunctional assessement of anatomical stenosis of coronary artery | Device | – |
Primary outcome
Rate of Major adverse cardiac events
Time frame: 24 months
Rate of the composite of cardiac death, recurrent myocardial infarction, and repeat revascularization
4 secondary outcomes
Rate of Target vessel failure
Time frame: 24 months
Rate of Death
Time frame: 24 months
Rate of myocardial infarction
Time frame: At 24 months
Rate of Repeat revascularization
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Ho Choo, M.D.,PhD principal investigator
The Catholic University of Korea
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by The Catholic University of Korea at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major adverse cardiac events (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.