Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05311111
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2022-03-17
Brief Title:
Efficacy and Safety of the Distal Radial Approach
Sponsor:
General Administration of Military Health Tunisia
Organization:
General Administration of Military Health Tunisia
Study Overview
Official Title:
Efficacy and Safety of the Distal Radial Approach in Percutaneous Coronary Interventions Protocol of a Randomized Controlled Non-inferiority Trial
Status:
UNKNOWN
Status Verified Date:
2022-03
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:
TunDRA
Brief Summary:
The aim of this non-inferiority trial is to determine if the distal radial access DRA during percutaneous coronary intervention PCI has an acceptable efficacy compared to the reference access through the conventional radial artery TRA with a lower rate of radial artery occlusion RAO in real life practice
Detailed Description:
The conventional radial approach is the recommended vascular access for percutaneous coronary interventions It is effective feasible but associated with a risk of occlusion of the radial artery
The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery However few clinical trials in real life were conducted in North African patients
This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach
This trial is a non-inferiority randomized controlled trial with two parallel arms distal radial approach and conventional radial approach Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included The two main endpoints are the puncture success rate with a non-inferiority margin of 10 and the rate of 30-day occlusion of the punctured radial artery
Secondary endpoints catheterization success crossover rate procedure time radial artery spasm bleeding complications QuickDASH score pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods
Avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas The results will provide the parameters related to the efficacy and safety of the distal radial approach so improving clinical practice
The distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery However few clinical trials in real life were conducted in North African patients
This trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach
This trial is a non-inferiority randomized controlled trial with two parallel arms distal radial approach and conventional radial approach Two hundred and fifty patients scheduled for percutaneous coronary intervention will be included The two main endpoints are the puncture success rate with a non-inferiority margin of 10 and the rate of 30-day occlusion of the punctured radial artery
Secondary endpoints catheterization success crossover rate procedure time radial artery spasm bleeding complications QuickDASH score pain score and operator satisfaction A single blind analysis will be led according to the per-protocol and intention-to-treat methods
Avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas The results will provide the parameters related to the efficacy and safety of the distal radial approach so improving clinical practice
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