NCT02935088

PRESSUREwire Study

Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,217 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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,

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Fractional Flow Reserve	Measurement of physiologic parameters

Timeline

• Start date: 2016-10-12
• Primary completion: 2019-03-22
• Completion: 2019-03-22
• First posted: 2016-10-17
• Last updated: 2020-02-07
• Results posted: 2020-02-07

Locations

71 sites across 15 countries: United States, Austria, Canada, Egypt, Estonia, Germany, Greece, India, Italy, Japan, Netherlands, Portugal, Saudi Arabia, Spain, United Kingdom