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Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women

Prospective Evaluation of Coronary Artery Disease in Women Presenting With Cardiac Ischemia: an Anatomic and Physiologic Study Comparing Fractional Flow Reserve (FFR) and Instantaneous Free-wave Ratio (iFR) on Cardiac Catheterization With Findings of Inducible Ischemia on Non-invasive Stress Imaging

NCT04599192•Yale University

View on ClinicalTrials.gov

Summary

A real world study to evaluate outcomes in women based on guideline identified fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) cutoffs for ischemia (ischemia defined as FFR ≤ 0.80 and iFR ≤ 0.89).

Detailed Description

The WOMEN FiRST (FFR iFR Revascularization Strategies Trial) study collects information from enrolled subjects to create a data repository. The data will be used to further elucidate recommendations for PCI of angiographically intermediate lesions (30-90% stenosis) in epicardial lesions in women by comparing FFR and iFR findings to findings of inducible ischemia on existing non-invasive stress imaging studies. Gender comparisons will also be made from archived and published research data sets from studies comprised up to 80% men. Data will also be stored long term for use in future undefined analyses.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female ≥ 18 years old at signing of informed consent
•2. Suspected myocardial ischemia or acute coronary syndrome
•3. Indication for non-invasive perfusion imaging study
•4. Indication for diagnostic catheterization
•5. Eligible for PCI
•6. Signed informed clinical procedural consent by subject or by surrogate

Exclusion Criteria

•1. Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker.
•2. Severe cardiomyopathy (ejection fraction \<30%)
•3. Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements
•4. Patients with left main coronary artery disease requiring revascularization
•5. Female of child baring age should have negative pregnancy test
•6. Subject is pregnant or breast feeding, or planning to become pregnant
•7. Contraindication to non-invasive stress imaging including severe claustrophobia, renal disease with GFR \<30 where CMR is indication, any metal in the body which is a contraindication to CMR, allergy to gadolinium contrast
•8. ICD or PPM

Locations (1)

Yale University School of Medicine - Section of Cardiology

New Haven, Connecticut, United States

Key Dates

Start Date

April 19, 2019

Primary Completion Date

April 10, 2026

Completion Date

April 30, 2029

Last Updated

November 5, 2025

Enrollment

500

ESTIMATED participants

Conditions

Coronary DiseasePercutaneous Coronary InterventionExercise TestMyocardial Perfusion ImagingCardiac Catheterization

Interventions

No study intervention

OTHER

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RECRUITINGPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women

Inclusion Criteria

Exclusion Criteria

ELEVATE High-Risk PCI Pivotal Study

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)