PRESSUREwire Study

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Treatments: Device: Fractional Flow Reserve

Study type: Observational

Funder types: Industry

Identifiers

NCT02935088

SJM-CIP-10136

Details and patient eligibility

About

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.

Full description

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,

Enrollment: 2,217 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design