Clinical trial NCT04911218: GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery
Official title: Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Access
Coronary Angiography
Radial Artery Occlusion
Keywords: arterial access
coronary angiography
radial access
distal radial access
radial artery occlusion
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of successful hemostasis at 30 minutes after sheath removal
timeFrame: At 30 minutes after sheath removal
Secondary outcomes:
measure: Crossover rate to conventional radial access
timeFrame: During the procedure
measure: Pain associated with the procedure (visual analog scale, VAS)
timeFrame: During the procedure
measure: Rate of hematoma modified EASY class≥II
timeFrame: Up to 24 hours after hemostatic device removal
measure: Rate of forearm radial artery occlusion
timeFrame: 7-10 days after the coronary angiography
measure: Rate of distal radial artery occlusion
timeFrame: 7-10 days after the coronary angiography
measure: Rate of fistula formation
timeFrame: 7-10 days after the coronary angiography
measure: Rate of pseudoaneurysm formation
timeFrame: 7-10 days after the coronary angiography
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
References: