Percutaneous Transluminal Coronary AngioplastyIRISFFRTandemNCT02797561
Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
An observational study of Percutaneous Transluminal Coronary Angioplasty, run by Seung-Jung Park at 12 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Transluminal Coronary Angioplasty
- What is being tested?
- 5 year Follow-up
- How many people
- 438 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 25 Jul 2016to 13 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with tandem lesion evaluated by FFR
Who may be able to join
- Tandem lesion evaluated by FFR
- Written consent
Who cannot join
- TIMI flow < 3
- Grafted vessel
- Left ventricular ejection fraction < 30%
- Severe calcification and/or severe tortuosity
- Uncontrolled coronary spasm
- Life expectancy < 2 years
- Planned high risk surgery
- Pregnancy or breast-feeding
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Gangwon National Univ. Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Chungnam National University Hospital
Daejeon
Inje University Ilsan Paik Hospital
Ilsan
Bundang CHA Hospital
Seongnam
Seoul National University Bundang hospital
Seongnam
Asan Medical Center
Seoul, Songpa-gu, 138-736
Seoul National University hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions.
- Being tested
- 5 year Follow-up
- Keywords
- Fractional flow reserve, Tandem, Percutaneous Coronary Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 year Follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| Tandem lesion evaluated by FFR | Not described Receives: Other: 5 year Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure
defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization
Measured: 2 years
Secondary outcomes (15)
all cause death
Measured: 5 years
cardiac death
Measured: 5 years
myocardial infarction
Measured: 5 years
target vessel revascularization
Measured: 5 years
target lesion revascularization
Measured: 5 years
Cardiac rehospitalization
Measured: 5 years
Cardiac death and myocardial infarction
Measured: 5 years
death, myocardial lnfarction, revascularization
related with stented lesion
Measured: 5 years
stroke
Measured: 5 years
stent thrombosis
Measured: 5 years
angina
Measured: 5 years
number of antianginal medications
Measured: 5 years
complications with FFR
Measured: 5 years
clinical predictors of events
Measured: 5 years
functional index
IMR(index of microcirculatory resistance), CFR(CFRthermo)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start25 Jul 2016
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Why it stopped: Early termination due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Transluminal Coronary AngioplastyStudies 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
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797561
- Sponsor's protocol ID
- AMCCV2016-12
- Acronym
- IRISFFRTandem
- Status last verified
- Apr 2026
- First submitted
- 8 Jun 2016
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
- ClinicalTrials.gov ID
- NCT02797561
- Acronym / sponsor ID
- IRISFFRTandem / AMCCV2016-12
- Keywords
- Fractional flow reserve, Tandem, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Early termination due to low enrollment
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tandem lesion evaluated by FFR | – | Other: 5 year Follow-up |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with tandem lesion evaluated by FFR
Key inclusion criteria (2 listed)
- Tandem lesion evaluated by FFR
- Written consent
Key exclusion criteria (8 listed)
- TIMI flow < 3
- Grafted vessel
- Left ventricular ejection fraction < 30%
- Severe calcification and/or severe tortuosity
- Uncontrolled coronary spasm
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 |
|---|---|---|
| 5 year Follow-up | Other | Tandem lesion evaluated by FFR |
Primary outcome
Target vessel failure
Time frame: 2 years
defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization
15 secondary outcomes
all cause death
Time frame: 5 years
cardiac death
Time frame: 5 years
myocardial infarction
Time frame: 5 years
target vessel revascularization
Time frame: 5 years
target lesion revascularization
Time frame: 5 years
Cardiac rehospitalization
Time frame: 5 years
Cardiac death and myocardial infarction
Time frame: 5 years
death, myocardial lnfarction, revascularization
Time frame: 5 years
stroke
Time frame: 5 years
stent thrombosis
Time frame: 5 years
angina
Time frame: 5 years
number of antianginal medications
Time frame: 5 years
complications with FFR
Time frame: 5 years
clinical predictors of events
Time frame: 5 years
functional index
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Early termination due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Transluminal Coronary Angioplasty, run by Seung-Jung Park at 12 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 was stopped early (reason given: Early termination due to low enrollment). Results are not available in the source record.
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?
Target vessel failure (time frame: 2 years). 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 15 Apr 2026.