PRESSUREwire Study

Completed

• Conditions: Acute Coronary Syndrome; Coronary Artery Disease

• Registration Number: NCT02935088
• Lead Sponsor: Abbott Medical Devices

Brief 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,

Study Timeline

• Study Start: 2016-10-12
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-13
• Study First Posted: 2016-10-17
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Results First Submitted: 2019-10-02
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Results First Posted: 2020-02-07
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2217

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (71)

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States

Providence Everett Medical Center; 🇺🇸 Everett, Washington, United States

Allgemeines Krankenhaus Linz; 🇦🇹 Linz, Austria

Krankenhaus Lainz; 🇦🇹 Vienna, Austria

London Health Sciences Centre; 🇨🇦 London, Canada

Hopital Sacre Coeur; 🇨🇦 Montreal, Canada

Aswan Cardiac Center; 🇪🇬 Aswan, Egypt

Al Dorrah Heart Care Hospital; 🇪🇬 Cairo, Egypt

Scroll for more (61 remaining)