Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05725616
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-02-02
Brief Title:
Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography Comparative Non-inferiority Study With the Radial Arterial Approach to the Wrist
Status:
RECRUITING
Status Verified Date:
2023-10
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:
COROTAB
Brief Summary:
The main objective of the study is to assess whether the distal radial arterial approach snuff box or back of the hand is not inferior to the radial arterial approach at the wrist in the management of coronary angiography for diagnostic purposes
Detailed Description:
Coronary angiography is the reference examination for anatomical exploration coronary arteries to determine the presence or absence of a predominantly obstructive coronary disease
Historically the femoral approach was the most common approach used in interventional cardiology The radial approach to the forearm presents multiple advantages over the femoral route and it became the gold standard approach to coronary angiography and intervention percutaneous coronary Although uncommon vascular complications related to the radial pathway exist
This is why a more distal radial approach above the long tendon extensor of the thumb at the level of the anatomical snuff box or downstream at the back of the hand was suggested more than 10 years ago This pathway is now an advantageous alternative to the radial approach of first intention both for the patient and for the practitioner
The two procedures are common today but few studies have been developed to compare the two approaches Therefore the main objective of the study is to assess whether the distal radial arterial approach snuff box or back of the hand is not inferior to the radial arterial approach at the wrist in the management of coronary angiography for diagnostic purposes
Historically the femoral approach was the most common approach used in interventional cardiology The radial approach to the forearm presents multiple advantages over the femoral route and it became the gold standard approach to coronary angiography and intervention percutaneous coronary Although uncommon vascular complications related to the radial pathway exist
This is why a more distal radial approach above the long tendon extensor of the thumb at the level of the anatomical snuff box or downstream at the back of the hand was suggested more than 10 years ago This pathway is now an advantageous alternative to the radial approach of first intention both for the patient and for the practitioner
The two procedures are common today but few studies have been developed to compare the two approaches Therefore the main objective of the study is to assess whether the distal radial arterial approach snuff box or back of the hand is not inferior to the radial arterial approach at the wrist in the management of coronary angiography for diagnostic purposes
Study Oversight
Has Oversight DMC:
None
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?:
None