Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03298126
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2017-09-17
Brief Title:
Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Coronary artery disease CAD is one of the major health concerns among other non-communicable diseases globally Cardiac catheterization is a diagnostic gold standard to determine the extent of disease in coronary arteries due to atherosclerosis Among the two approaches for cardiac catheterization trans-radial approach has gained more popularity than conventional trans-femoral approach over the past decade with availability of compression devices for radial artery that assures lesser risk of bleeding and hematoma and has translated into increased patient comfort and early mobility post procedure Radial artery occlusion is a common complication of trans-radial procedures often ignored by the operator after procedure due to dual blood supply by ulnar artery Although clinically silent usually it necessitate the need of monitoring radial artery for patency because of risk of limited trans-radial access laterReportedly RAO occurs in about 10 of cardiac catheterizations compression devices applied after sheath removal may be a contributing factor to radial artery occlusion because of selective pressure for extended time duration 3-4 hours Various protocols have been developed to remove TR band by different institutions across the globe and have been tested to assess post procedure complications To the best of what we know there exists no standard protocol to deflate TR band Also the current protocol in practice at our institution has not been evaluated against other protocols that are followed in other institution across the globe claiming lesser post procedure complications Hence our aim was to test through a randomized trial whether our hospital standard protocol is non-inferior to the existing international protocol of Cohen Alfonso that promises lesser complication rate
Detailed Description:
None
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