Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02281110
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2014-10-01
Brief Title:
The REAL Registry for Utilization of iFR in Assessing Coronary Stenoses
Sponsor:
Volcano Corporation
Organization:
Volcano Corporation
Study Overview
Official Title:
A Prospective Observational Non-randomized European Multi-center Registry Collecting Real Life Information for the Utilization of Instantaneous Wave Free Ratio in Assessing Coronary Stenosis Relevance in the Multi-vessel Disease Patients Population
Status:
COMPLETED
Status Verified Date:
2016-05
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:
DEFINE REAL
Brief Summary:
The purpose of this registry is to collect real life information and to document the performance and user friendliness of iFR in daily diagnostic practice and treatment strategies for MVD patients undergoing cardiac catheterization
Detailed Description:
The REAL Registry will enroll a maximum of 3000 patients in approximately 300 sites across multiple European and Middle East countries where product has received CE approval and is marketed An average of 10 cases with a maximum of 50 patients will be enrolled per participating site
No follow-up will be performed The REAL Registry will only collect data during diagnostic angiogram or PCI procedure when performed
No follow-up will be performed The REAL Registry will only collect data during diagnostic angiogram or PCI procedure when performed
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