Resting Full-cycle Ratio in Side Branch
PRospEctive Evaluation of DIagnostiC Performances of resTing Full-cycle rAtio in Coronary Bifurcation LEsion (PREDICTABLE Study)
1 other identifier
observational
286
1 country
1
Brief Summary
The goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (RFR) in side branch lesion. We aims to evaluate whether the diagnostic performance of RFR in the side branch lesion is non-inferior compared to that in the main vessel lesion RFR and FFR measurements will be performed to define functional significance in patients with side branch lesion with or without main vessel lesion
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2020
CompletedFirst Submitted
Initial submission to the registry
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 10, 2023
October 1, 2023
4.5 years
October 3, 2023
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
diagnostic sensitivity of RFR in side branch lesions
diagnostic sensitivity of RFR to predict FFR \< 0.80
during index coronary angiography
Secondary Outcomes (1)
Specificity, positive predictability, negative predictability, diagnostic accuracy, area under the curve (AUC) value in side branch
during index coronary angiography
Interventions
RFR and FFR measurements in main vessel and side branch lesions
Eligibility Criteria
Patients with side branch lesion, who need functional evaluation
You may qualify if:
- Patients with side branch lesion, who need functional evaluation
You may not qualify if:
- Severe LV systolic dysfunction (LVEF \<30%)
- Culprit vessel in acute coronary syndrome
- Donor vessel to supply chronic total occlusion lesion of non-target vessel
- Symptomatic valvular heart disease or cardiomyopathy
- Too much overlapping or severe tortuosity to disrupt quantitative coronary analysis
- Previous bypass surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sejong General Hospitallead
- Soon Chun Hyang Universitycollaborator
- Keimyung University Dongsan Medical Centercollaborator
- Hanyang University Seoul Hospitalcollaborator
Study Sites (1)
Sejong General Hospital
Bucheon-si, Gyeonggi-do, 14574, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- 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
January 8, 2020
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share