Coronary Artery DiseaseNCT02475291
Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery
An observational study of Coronary Artery Disease and Stenosis, run by Yonsei University at 1 site in South Korea.
Trial summary
Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Stenosis
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to May 2016
- 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 significant lesions with more than 70% diameter stenosis at proximal part of one or more major coronary arteries, regardless of revascularization strategy.
Who may be able to join
- Patients ≥ 19 years old
- Typical angina
- Stable or unstable angina pectoris
- At least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
- Reference vessel diameter of target lesion ≥3.0 mm
- Normal LV ejection fraction (≥50%) without wall motion abnormality by echocardiography
Who cannot join
- Previous myocardial infarction
- Previous coronary bypass graft surgery
- Cardiogenic shock
- Multiple lesions in the vessel of interest
- Contraindication or hypersensitivity to adenosine or contrast media
- Reduced coronary blood flow (TIMI flow grade <3) in the vessel of interest
Show all 9Show fewer
- Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions
- Pregnant women or women with potential childbearing
- Inability to understand or read the informed content
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of FFR for all angiographically significant stenoses would add considerable time, cost, and complexity to each PCI procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. Although the guideline mentioned that FFR may not be useful in very high grade lesions (angiographically >90%) which always have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80 obtained by angiographic parameters including degree of stenosis, lesion location and vessel size. It would be valuable to find more precise criteria available by conventional angiography for discrimination of functional stenosis in way to reduce the risk of additional procedure. For the purpose, the investigators will perform FFR in the lesions with significant stenosis (>70% diameter stenosis by visual estimation) and compare the angiographic parameters and FFR values in the study.
- Conditions
- Coronary Artery Disease, Stenosis
- Medical subject headings
- Coronary Artery Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Significant coronary lesions | Significant lesions with more than 70% diameter stenosis at proximal major coronary arteri(es). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis
Coronary lesions with FFR <0.80 will be defined to be related with ischemia. Because all lesions in the study will be angiographically significant stenosis with DS >70%, agreement of diagnosis between FFR-defined ischemia and angiographically significant stenosis will be obtained by the ratio of lesions with FFR <0.80.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475291
- Sponsor's protocol ID
- 1-2015-0025
- Status last verified
- Jul 2016
- First submitted
- 8 Jun 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery
- ClinicalTrials.gov ID
- NCT02475291
- Acronym / sponsor ID
- 1-2015-0025
- Conditions
- Coronary Artery Disease, Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Jun 2015 (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.
Fractional flow reserve (FFR) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. Recent ESC guidelines referred to the usefulness of FFR extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. However, FFR requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. More routine use of FFR for all angiographically significant stenoses would add considerable time, cost, and complexity to each PCI procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. Although the guideline mentioned that FFR may not be useful in very high grade lesions (angiographically >90%) which always have an FFR <0.80, it have not been revealed yet proper criteria to predict FFR <0.80 obtained by angiographic parameters including degree of stenosis, lesion location and vessel size. It would be valuable to find more precise criteria available by conventional angiography for discrimination of functional stenosis in way to reduce the risk of additional procedure. For the purpose, the investigators will perform FFR in the lesions with significant stenosis (>70% diameter stenosis by visual estimation) and compare the angiographic parameters and FFR values in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Significant coronary lesions | – | –Significant lesions with more than 70% diameter stenosis at proximal major coronary arteri(es). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with significant lesions with more than 70% diameter stenosis at proximal part of one or more major coronary arteries, regardless of revascularization strategy.
Key inclusion criteria (6 listed)
- Patients ≥ 19 years old
- Typical angina
- Stable or unstable angina pectoris
- At least one or more major epicardial coronary arteries with significant stenosis (>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery
- Reference vessel diameter of target lesion ≥3.0 mm
Key exclusion criteria (9 listed)
- Previous myocardial infarction
- Previous coronary bypass graft surgery
- Cardiogenic shock
- Multiple lesions in the vessel of interest
- Contraindication or hypersensitivity to adenosine or contrast media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis
Time frame: 1day
Coronary lesions with FFR <0.80 will be defined to be related with ischemia. Because all lesions in the study will be angiographically significant stenosis with DS >70%, agreement of diagnosis between FFR-defined ischemia and angiographically significant stenosis will be obtained by the ratio of lesions with FFR <0.80.
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 27 Jul 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Stenosis, run by Yonsei University at 1 site 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 6 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 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Agreement of diagnosis between FFR-documented ischemia and angiographically significant stenosis (time frame: 1day). 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 27 Jul 2016.