Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 6:59 AM
Study NCT ID:
NCT03237169
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2017-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
Sponsor:
Centro Hospitalar Lisboa Ocidental
Organization:
Study Overview
Official Title:
Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
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:
PREDICT
Brief Summary:
To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.
Detailed Description:
Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: