NCT06075160Recruiting
Resting Full-cycle Ratio (RFR)-Guided Revascularization
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)
Source: ClinicalTrials.gov · Last updated 10 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1167 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 27 Jul 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Sejong General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06075160
What you commit to
- Study type: Observational
- Planned participants: 1167
- From 27 Jul 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CABG with patent grafts to the interrogated vessel
Other illness
- Culprit vessel in acute coronary syndrome
- Symptomatic valvular heart disease or cardiomyopathy
- Hemodynamic instability at the time of intervention (heart rate \<50 beats per minute, systolic blood pressure \<90mmHg)
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance
Lab values
- Severe left ventricular systolic dysfunction (LVEF \<30%)
Other
- Cardiogenic shock
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 20 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.