Coronary Artery DiseaseNCT06075160
Resting Full-cycle Ratio (RFR)-Guided Revascularization
An observational study of Coronary Artery Disease, run by Sejong General Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the clinical outcomes of a 2-year follow-up to determine whether RFR-guided coronary intervention is non-inferior to FFR-guided coronary intervention in patients with intermediate coronary stenosis. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Resting full-cycle ratio (RFR)-guided revascularization and Fractional flow ratio (FFR)-guided revascularization
- How many people
- 1,167 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2022to 31 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate coronary artery stenosis, who need functional evaluation
Who may be able to join
- Patients with intermediate coronary artery stenosis (visually 50-90% diameter stenosis) who decided to undergoing a RFR-guided coronary intervention according to clinical necessity
- Patients who voluntarily decided to participate in this study and signed informed consent
Who cannot join
- Severe left ventricular systolic dysfunction (LVEF <30%)
- Cardiogenic shock
- Culprit vessel in acute coronary syndrome
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Symptomatic valvular heart disease or cardiomyopathy
- Hemodynamic instability at the time of intervention (heart rate <50 beats per minute, systolic blood pressure <90mmHg)
Show all 9Show fewer
- Previous CABG with patent grafts to the interrogated vessel
- Pregnancy or breastfeeding
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, 14574
Hyun-Jong Lee, MD, PhD, 82-10-6217-9315, untouchables@sejongh.co.kr
About this study
Official title: Prospective Evaluation of Long-term Clinical Outcomes After Resting Full-cycle Ratio (RFR)-Guided Percutaneous Coronary Revascularization; A Multi-center, International, Single Arm Interventional, Comparing Registry (COMFORT Study)
The purpose of this study is to compare the clinical outcomes of a 2-year follow-up to determine whether RFR-guided coronary intervention is non-inferior to FFR-guided coronary intervention in patients with intermediate coronary stenosis.
Read the detailed description
Myocardial ischemia is a key determinant of clinical prognosis in patients with coronary artery disease. In this regard, functional assessment of intermediate coronary stenoses with transtenotic pressure ratios provides a more accurate measure of stenosis-derived myocardial ischemia in comparison to conventional coronary angiography (3-5). One of the major clinical benefit of fractional flow reserve (FFR) is that, by acting as a gatekeeper, non-ischemia-causing lesions suitable for optimal medical treatment can be accurately identified, avoiding unnecessary coronary stenting. However, despite being support with the highest level of recommendation by the current guidelines for guiding clinical-decision making, adoption of FFR in the real world practice is still very low, mainly due to the need of hyperemic agents like adenosine that frequently cause patient discomfort, and time consumption. To overcome such limitations of pressure-wire derived index from the need of adenosine, other alternatives have been looking for over the last years. Instantaneous wave-free ratio (iFR), a resting trans-stenotic pressure index obtained as the ratio of distal coronary pressure to aortic pressure during the diastolic wave-free period, demonstrated a good diagnostic accuracy to define functional significance of coronary lesions without need of adenosine, using FFR as reference. Recently, two large, randomized trials demonstrated that iFR-guided coronary revascularization is clinically non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Accordingly, like FFR, iFR is now receiving the highest level of recommendations to guide clinical decision making in patients with stable intermediate coronary stenosis. A new adenosine-free index, the resting full-cycle ratio (RFR), has recently emerged. RFR is defined as the lowest ratio of intracoronary distal pressure to aortic pressure under resting condition, irrespective of systole or diastole, and has demonstrated equivalent diagnostic performance to iFR. RFR has an advantage over iFR, because it is not limited by sensitive land marking of components of the pressure waveform unlike iFR.
This novel physiologic index without the need of adenosine has the potential to increase the worldwide adoption of coronary physiology in guiding coronary revascularization in daily clinical practice. However, there is a paucity of important data regarding clinical outcomes of RFR-guided revascularization strategy. We hypothesize long-term clinical outcome of RFR-guided revascularization is non-inferior to that of FFR-guided revascularization, and it reduce the rate of PCI than FFR-guided revascularization. Therefore, we sought to investigate the long-term effectiveness and safety of RFR-based decision making in patients with one or more intermediate coronary stenosis, and to assess whether it is non-inferior to FFR-guided revascularization.
- Conditions
- Coronary Artery Disease
- Being tested
- Resting full-cycle ratio (RFR)-guided revascularization, Fractional flow ratio (FFR)-guided revascularization
- Keywords
- physiologic assessment, intermediate stenosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting full-cycle ratio (RFR)-guided revascularizationDiagnostic test
The decision of coronary intervention is based on an RFR cut-value of 0.89. If RFR ≤ 0.89, target lesion will be revascularized, and if RFR > 0.89, PCI will be deferred. However, even if RFR ≤ 0.89, PCI can be deferred if the RFR gradient of the lesion ≤ 0.02, or if the diffused type of stenosis, because physiological gain is expected to be very low.
Fractional flow ratio (FFR)-guided revascularizationDiagnostic test
Study participants of FFR-guided PCI arm will be selected from a large-scaled, ongoing FFR registry. The decision of coronary intervention is based on an FFR cut-value of 0.80. If FFR ≤ 0.80, target lesion will be revascularized, and if RFR > 0.80, PCI will be deferred.
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of death from any cause, non-fatal myocardial infarction, or unplanned revascularization
Measured: At 2-year
Secondary outcomes (9)
Target lesion failure
A composite of cardiac death, target vessel MI, or target lesion revascularization
Measured: At 2-year
Target vessel failure
A composite of cardiac death, target vessel MI, or target vessel revascularization
Measured: At 2-year
Death from any cause
Measured: At 2-year
Cardiovascular death
Measured: At 2-year
Cardiac death or non-fatal MI
Measured: At 2-year
Non-fatal MI
Measured: At 2-year
Any unplanned revascularization
Measured: At 2-year
Target vessel revascularization
Measured: At 2-year
Target lesion revascularization
Measured: At 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start27 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- 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
- 1,167 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sejong General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wonju Severance Christian Hospital, Hospital San Carlos, Madrid, Seoul St. Mary's Hospital, Dong-A University Hospital, Gyeongsang National University Hospital, Soon Chun Hyang University, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Seoul National University Bundang Hospital, Kosin University Gospel Hospital, Pusan National University Hospital
- Responsible party
- Principal investigator, Hyun Jong Lee, Sejong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075160
- Sponsor's protocol ID
- COMFORT Vesion 2.6
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Long-term Clinical Outcomes After Resting Full-cycle Ratio (RFR)-Guided Percutaneous Coronary Revascularization; A Multi-center, International, Single Arm Interventional, Comparing Registry (COMFORT Study)
- ClinicalTrials.gov ID
- NCT06075160
- Acronym / sponsor ID
- COMFORT Vesion 2.6
- Conditions
- Coronary Artery Disease
- Keywords
- physiologic assessment, intermediate stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,167 participants (estimated)
- Lead sponsor
- Sejong General HospitalUniversity, hospital or other
- Collaborators
- Wonju Severance Christian Hospital, Hospital San Carlos, Madrid, Seoul St. Mary's Hospital, Dong-A University Hospital, Gyeongsang National University Hospital, Soon Chun Hyang University, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Seoul National University Bundang Hospital, Kosin University Gospel Hospital, Pusan National University Hospital
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Oct 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.
The purpose of this study is to compare the clinical outcomes of a 2-year follow-up to determine whether RFR-guided coronary intervention is non-inferior to FFR-guided coronary intervention in patients with intermediate coronary stenosis.
Detailed description
Myocardial ischemia is a key determinant of clinical prognosis in patients with coronary artery disease. In this regard, functional assessment of intermediate coronary stenoses with transtenotic pressure ratios provides a more accurate measure of stenosis-derived myocardial ischemia in comparison to conventional coronary angiography (3-5). One of the major clinical benefit of fractional flow reserve (FFR) is that, by acting as a gatekeeper, non-ischemia-causing lesions suitable for optimal medical treatment can be accurately identified, avoiding unnecessary coronary stenting. However, despite being support with the highest level of recommendation by the current guidelines for guiding clinical-decision making, adoption of FFR in the real world practice is still very low, mainly due to the need of hyperemic agents like adenosine that frequently cause patient discomfort, and time consumption. To overcome such limitations of pressure-wire derived index from the need of adenosine, other alternatives have been looking for over the last years. Instantaneous wave-free ratio (iFR), a resting trans-stenotic pressure index obtained as the ratio of distal coronary pressure to aortic pressure during the diastolic wave-free period, demonstrated a good diagnostic accuracy to define functional significance of coronary lesions without need of adenosine, using FFR as reference. Recently, two large, randomized trials demonstrated that iFR-guided coronary revascularization is clinically non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Accordingly, like FFR, iFR is now receiving the highest level of recommendations to guide clinical decision making in patients with stable intermediate coronary stenosis. A new adenosine-free index, the resting full-cycle ratio (RFR), has recently emerged. RFR is defined as the lowest ratio of intracoronary distal pressure to aortic pressure under resting condition, irrespective of systole or diastole, and has demonstrated equivalent diagnostic performance to iFR. RFR has an advantage over iFR, because it is not limited by sensitive land marking of components of the pressure waveform unlike iFR.
This novel physiologic index without the need of adenosine has the potential to increase the worldwide adoption of coronary physiology in guiding coronary revascularization in daily clinical practice. However, there is a paucity of important data regarding clinical outcomes of RFR-guided revascularization strategy. We hypothesize long-term clinical outcome of RFR-guided revascularization is non-inferior to that of FFR-guided revascularization, and it reduce the rate of PCI than FFR-guided revascularization. Therefore, we sought to investigate the long-term effectiveness and safety of RFR-based decision making in patients with one or more intermediate coronary stenosis, and to assess whether it is non-inferior to FFR-guided revascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate coronary artery stenosis, who need functional evaluation
Key inclusion criteria (2 listed)
- Patients with intermediate coronary artery stenosis (visually 50-90% diameter stenosis) who decided to undergoing a RFR-guided coronary intervention according to clinical necessity
- Patients who voluntarily decided to participate in this study and signed informed consent
Key exclusion criteria (9 listed)
- Severe left ventricular systolic dysfunction (LVEF <30%)
- Cardiogenic shock
- Culprit vessel in acute coronary syndrome
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Symptomatic valvular heart disease or cardiomyopathy
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 |
|---|---|---|
| Resting full-cycle ratio (RFR)-guided revascularizationThe decision of coronary intervention is based on an RFR cut-value of 0.89. If RFR ≤ 0.89, target lesion will be revascularized, and if RFR > 0.89, PCI will be deferred. However, even if RFR ≤ 0.89, PCI can be deferred if the RFR gradient of the lesion ≤ 0.02, or if the diffused type of stenosis, because physiological gain is expected to be very low. | Diagnostic test | – |
| Fractional flow ratio (FFR)-guided revascularizationStudy participants of FFR-guided PCI arm will be selected from a large-scaled, ongoing FFR registry. The decision of coronary intervention is based on an FFR cut-value of 0.80. If FFR ≤ 0.80, target lesion will be revascularized, and if RFR > 0.80, PCI will be deferred. | Diagnostic test | – |
Primary outcome
A composite of death from any cause, non-fatal myocardial infarction, or unplanned revascularization
Time frame: At 2-year
9 secondary outcomes
Target lesion failure
Time frame: At 2-year
Target vessel failure
Time frame: At 2-year
Death from any cause
Time frame: At 2-year
Cardiovascular death
Time frame: At 2-year
Cardiac death or non-fatal MI
Time frame: At 2-year
Non-fatal MI
Time frame: At 2-year
Any unplanned revascularization
Time frame: At 2-year
Target vessel revascularization
Time frame: At 2-year
Target lesion revascularization
Time frame: At 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
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, run by Sejong General Hospital 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 2 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: looking for participants now, as of the sponsor's last update on 10 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jong Lee, MD, PhD (82-10-6217-9315, untouchables00@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of death from any cause, non-fatal myocardial infarction, or unplanned revascularization (time frame: At 2-year). 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 10 Oct 2023.