NCT06075160

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,167

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jul 2022Dec 2026

Study Start

First participant enrolled

July 27, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4.4 years

First QC Date

October 3, 2023

Last Update Submit

October 3, 2023

Conditions

Coronary Artery Disease

Keywords

physiologic assessmentintermediate stenosis

Outcome Measures

Primary Outcomes (1)

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

    At 2-year

Secondary Outcomes (9)

  • Target lesion failure

    At 2-year

  • Target vessel failure

    At 2-year

  • Death from any cause

    At 2-year

  • Cardiovascular death

    At 2-year

  • Cardiac death or non-fatal MI

    At 2-year

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intermediate coronary artery stenosis, who need functional evaluation

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Hyun-Jong Lee, MD, PhD

CONTACT

82-10-6217-9315untouchables00@hanmail.net

Su Jung Lee, RN

CONTACT

82-32-340-1812bjwwoki0827@daum.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

July 27, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)