Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02935088
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2016-10-13
Brief Title:
PRESSUREwire Study
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Practical Evaluation of Fractional Flow Reserve FFR and Its Associated Alternate Indices During Routine Clinical Procedures
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None