Arterial Access, Coronary Angiography, Radial Artery Occlusion
Conditions
Keywords
arterial access, coronary angiography, radial access, distal radial access, radial artery occlusion
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 access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% 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.
Detailed description
Patients fulfilling the enrollment criteria will be randomized 1:1 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.
Interventions
DEVICEGlideSheath Slender 5Fr arterial sheath
Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
DEVICEConventional 5Fr arterial sheath
Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for coronary angiography * Age\>18 years * Informed consent
Exclusion criteria
* Non-palpable right radial artery * Prior CABG * STEMI * Prior right transaradial intervention within the previous 2 months * Hemodynamic instability * Anatomical restrictions (fistula orthopaedic problems, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successful hemostasis at 30 minutes after sheath removal | At 30 minutes after sheath removal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crossover rate to conventional radial access | During the procedure | — |
| Pain associated with the procedure (visual analog scale, VAS) | During the procedure | 0-10, 0: no pain, 10: worst pain possible |
| Rate of hematoma modified EASY class≥II | Up to 24 hours after hemostatic device removal | — |
| Rate of forearm radial artery occlusion | 7-10 days after the coronary angiography | — |
| Rate of distal radial artery occlusion | 7-10 days after the coronary angiography | — |
| Rate of fistula formation | 7-10 days after the coronary angiography | — |
| Rate of pseudoaneurysm formation | 7-10 days after the coronary angiography | — |
Countries
Greece
Outcome results
None listed