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NCT Number: NCT06075160

Resting Full-cycle Ratio (RFR)-Guided Revascularization

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu

Bucheon-si, Gyeonggi-do, 14574, South Korea

Location status: Recruiting

Location contact

Hyun-Jong Lee, MD, PhD

CONTACT

[email protected]

82-10-6217-9315

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Resting full-cycle ratio (RFR)-guided revascularization

Diagnostic 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 revascularization

Diagnostic 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.

Primary outcomes

  1. A composite of death from any cause, non-fatal myocardial infarction, or unplanned revascularization

    Time frame: At 2-year

Secondary outcomes

  1. Target lesion failure

    Time frame: At 2-year

    A composite of cardiac death, target vessel MI, or target lesion revascularization

  2. Target vessel failure

    Time frame: At 2-year

    A composite of cardiac death, target vessel MI, or target vessel revascularization

  3. Death from any cause

    Time frame: At 2-year

  4. Cardiovascular death

    Time frame: At 2-year

  5. Cardiac death or non-fatal MI

    Time frame: At 2-year

  6. Non-fatal MI

    Time frame: At 2-year

  7. Any unplanned revascularization

    Time frame: At 2-year

  8. Target vessel revascularization

    Time frame: At 2-year

  9. Target lesion revascularization

    Time frame: At 2-year

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun-Jong Lee, MD, PhD

CONTACT

[email protected]

82-10-6217-9315

Su Jung Lee, RN

CONTACT

[email protected]

82-32-340-1812

Sponsors and collaborators

Lead sponsor

Sejong General Hospital

Other

Collaborators

  • Dong-A University Hospital
  • Gyeongsang National University Hospital
  • Hospital San Carlos, Madrid
  • Keimyung University Dongsan Medical Center
  • Kosin University Gospel Hospital
  • Pusan National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul St. Mary's Hospital
  • Soon Chun Hyang University
  • Ulsan University Hospital
  • Wonju Severance Christian Hospital

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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