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CTFFR and Prediction of Non-Significant CAD Lesions

ConditionChronic Coronary Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorShiraz University of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NIFFR

    Diagnostic test

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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: nonsignificant NIFFRExperimental treatment 1 intervention
Group B: significant NIFFRActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with MACE

Number of patients with Major adverse cardiac events,which included cardiac-related death, acute coronary syndrome (ACS), unexpected revascularisation, and hospitalization for cardiac reasons, stroke

Time frame
1 year
2

Number of patients with bleeding

Number of patients with major or minor bleeding based on BARC classification

Time frame
1 year

Secondary outcomes

1

Number of patients with dyspnoea

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shiraz University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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