PRESSUREwire Study

Abbott Medical Devices2,217 enrolled

Overview

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.

The purpose of this study is to understand routine use of FFR 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. The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,

Study Type

OBSERVATIONAL

Enrollment

2,217

Conditions

Coronary Artery Disease Acute Coronary Syndrome

Interventions

Fractional Flow ReserveDEVICE

Measurement of physiologic parameters

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (71)

Outcomes

Primary Outcomes

Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices

Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization. Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR \> 0.8).

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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