Skip to content

CTFFR and Prediction of Non-Significant CAD Lesions

Evaluation of the Ability of CTFFR to Determine Non-significant Lesions of Coronary Disease Based on MACE in One-year Follow-up of Patients (Seeing Beyond the Stenosis: CTFFR and MACE in a One-Year Follow-Up)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06979427
Enrollment
250
Registered
2025-05-19
Start date
2024-01-01
Completion date
2026-09-01
Last updated
2025-05-21

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

Conditions

Chronic Coronary Syndrome

Keywords

Chronic Coronary Syndrome, Major adverse coronary events (MACE), fractional flow reserve, coronary CT angiography

Brief summary

In this prospective cohort study, 250 patients with suspected or known CAD and at least one intermediate coronary lesion (50-70% stenosis) who had a NiFFR value greater than 0.80 underwent coronary computed tomography angiography (CCTA) with NiFFR assessment. Patients were followed for one year to monitor for MACE

Detailed description

This prospective cohort includes people with known or suspected CAD who had both CCTA and ICA with this index (FFR) measurements. Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing. Data about the patients was acquired from the Professor Kojuri registry. The database provided demographic information for instance age, gender, CAD family history, prior CAD history, hypertension (HTN), diabetes mellitus (DM), and hyperlipidaemia (HLP). The prevalence of cigarette smoking and the ejection fraction of the left ventricle. Lesion and Vessel Characteristics were also collected from registry. The target vessel was identified (LAD, RCA, LCX, or LMC), the lesion was located (proximal, mid, or bifurcation), the vessel diameters were measured (proximal, distal, stenotic), and the lesion length was determined. Measurements were taken using CCTA datasets using semi-automated software methods. Patients were clinically monitored for one year after examination. The primary outcome was the occurrence of major cardiovascular consequences, or MACE, which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons. Throughout the one-year study period, all participants were visited every three months and followed up with phone calls.

Interventions

DIAGNOSTIC_TESTNIFFR

Fractional flow reserve derived from CT angiography from lesion between 50-70%

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

NIFFR of coronary less than 0.8

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients were enrolled if they had at least one intermediate coronary lesion (classified as 50-70% diameter stenosis on visual judgment) on CCTA and then underwent FFR testing

Exclusion criteria

* Patients having past coronary artery bypass graft surgery (CABG) * previous PCI in the target vascular * significant renal impairment define with eGFR \< 30 mL/min/1.73 m² * contrast allergy * poor image quality that prevented appropriate CCTA or CT-FFR analysis

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with MACE1 yearNumber of patients with Major adverse cardiac events,which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons, stroke
Number of patients with bleeding1 yearNumber of patients with major or minor bleeding based on BARC classification

Secondary

MeasureTime frameDescription
Number of patients with dyspnoea1 yearNumber of patients with minor and major dyspnoea ( based on that it affect daily activity or tolerable or not)

Countries

Iran

Contacts

Primary Contactjavad UOM kojuri
kojurij@yahoo.com09171115083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026