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Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.

Clinical Outcomes of Patients With Deferred Revascularization Based on Fractional Flow Reserve (FFR) and Instantaneous Wave-free Ratio (iFR) Negative Coronary Artery Lesions in Pakistani Population

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05240768
Enrollment
345
Registered
2022-02-15
Start date
2020-01-10
Completion date
2021-08-20
Last updated
2022-02-15

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

Conditions

Coronary Artery Disease

Brief summary

The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.

Detailed description

Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration. This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR. Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.

Interventions

DIAGNOSTIC_TESTFractional flow reserve, instantaneous wave-free Ratio

Clinical outcomes observed for patients with moderate coronary lesions in whom coronary revascularization was deferred due to a negative physiologic study.

Sponsors

Aga Khan University Hospital, Pakistan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Patients who had intermediate to severe coronary lesions on coronary angiogram. * Patients who had negative FFR \>0.80 or iFR \>0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.

Exclusion criteria

* Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded. * Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac death29 monthsNumber of participants who died due to sudden cardiac arrest, sudden death due to acute MI and death due to heart failure or cardiogenic shock
Non-fatal myocardial infarction29 monthsNumber of patients suffering from Myocardial infarction but did not die.
Target vessel revascularization.29 monthsRepeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026