N/A
Completed N=2,217
PRESSUREwire Study
Source: ClinicalTrials.gov NCT02935088 ↗Enrolled (actual)
2,217
Serious AEs
4.8%
Results posted
Feb 2020
Primary outcomePrimary: Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices — 50; 51; 19; 30 Participants
Summary
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices |
50; 51; 19; 30; 20; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
- Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration
- Patient signs and dates written informed consent
- Patient is eighteen years of age or older at the time of consent
Exclusion Criteria
- Patient has extremely tortuous or calcified coronary arteries
- Patient with a patent coronary artery bypass graft to the target vessel
Data sourced from ClinicalTrials.gov (NCT02935088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.