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Long-term clinical outcomes after resting full-cycle ratio (RFR)-guided PCI

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 study (COMFORT study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007441
Enrollment
1167
Registered
2022-06-23
Start date
2022-07-27
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Patients with Stable intermittent coronary stenosis (visually 50-90% diameter stenosis) are targeted. For lesions that do not stable intermittent coronary stenosis, coronary interv

Sponsors

BUCHEON SEJONG HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age > 19 years of age 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

Exclusion criteria: 1) Severe LV systolic dysfunction (LVEF <30%) 2) Cardiogenic shock 3) Culprit vessel in acute coronary syndrome 4) Donor vessel to supply chronic total occlusion lesion of non-target vessel 5) Symptomatic valvular heart disease or cardiomyopathy 6) Hemodynamic instability at the time of intervention (heart rate <50 beats per minute, systolic blood pressure <90mmHg) 7) Previous CABG with patent grafts to the interrogated vessel 8) Pregnancy or breastfeeding 9) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Design outcomes

Primary

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

Secondary

MeasureTime frame
Target lesion failure: cardiac death, target vessel MI, or target lesion revascularization;Target vessel failure: cardiac death, target vessel MI, or target vessel revascularization;Death from any cause ;Cardiovascular death;Cardiac death or non-fatal MI;Non-fatal MI ;Any unplanned revascularization;Target vessel revascularization ;Target lesion revascularization

Countries

Korea, Republic of

Contacts

Public ContactHyun-Jong Lee

Sejong General Hospital

untouchables00@hanmail.net+82-32-340-1681

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 23, 2026