Trials / Enrolling By Invitation
Enrolling By InvitationNCT04599192
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
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Coronary Disease
- Percutaneous Coronary Intervention
- Exercise Test
- Myocardial Perfusion Imaging
- Cardiac Catheterization
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No study intervention | The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care. |
Timeline
- Start date
- 2019-04-19
- Primary completion
- 2026-04-10
- Completion
- 2029-04-30
- First posted
- 2020-10-22
- Last updated
- 2025-11-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04599192. Inclusion in this directory is not an endorsement.