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

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.

Inclusion criteria

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

Exclusion criteria

• Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker.
• Severe cardiomyopathy (ejection fraction <30%)
• Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements
• Patients with left main coronary artery disease requiring revascularization
• Female of child baring age should have negative pregnancy test
• Subject is pregnant or breast feeding, or planning to become pregnant
• 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
• ICD or PPM