Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04911218
Status:
COMPLETED
Last Update Posted:
2021-12-14
First Post:
2021-05-20
Brief Title:
GlideSheath Slender Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery
Sponsor:
University Hospital of Patras
Organization:
University Hospital of Patras
Study Overview
Official Title:
Randomized Comparison of GlideSheath Slender Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery Anatomical Snuffbox
Status:
COMPLETED
Status Verified Date:
2021-12
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:
Transradial approach has become the default arterial access for coronary angiography CAG and percutaneous coronary intervention PCI mainly due to lower incidence of bleeding compared to transfemoral access1 However TRA is not deprived of local access site complications such as radial artery occlusion RAO occurring in approximately 52 of patients compartment syndrome pseudoaneurysm hematoma and arteriovenous fistula Recently a novel approach has been proposed the access through the distal radial artery distal transradial access dTRA located in the anatomical snuffbox Initial studies regarding the dRA have shown feasibility and benefits including shorter hemostasis time fewer local access site complications and potentially lower incidence of RAO
GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths As a result the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths
The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis sheath insertion time crossover rate to conventional radial access pain associated with the procedure and incidence of local access site complications RAO distal radial artery occlusion fistula hematoma in patients undergoing diagnostic angiography through the distal radial artery
GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths As a result the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths
The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis sheath insertion time crossover rate to conventional radial access pain associated with the procedure and incidence of local access site complications RAO distal radial artery occlusion fistula hematoma in patients undergoing diagnostic angiography through the distal radial artery
Detailed Description:
Patients fulfilling the enrollment criteria will be randomized 11 to GlideSheath Slender versus conventional 5Fr arterial sheath for access through the distal radial artery dTRA In case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis
For randomized patients sheath insertion time necessity for crossover to conventional radial access pain associated with the procedure visual pain scale and occurrence of hematoma will be recorded Follow-up ultrasound 7-10 days after the procedure for detection of RAO distal radial artery occlusion and fistula formation will be performed
For randomized patients sheath insertion time necessity for crossover to conventional radial access pain associated with the procedure visual pain scale and occurrence of hematoma will be recorded Follow-up ultrasound 7-10 days after the procedure for detection of RAO distal radial artery occlusion and fistula formation will be performed
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