GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery

Coronary Angiography Clinical Trial

Official title:

Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911218
• Other study ID #: 1762/22.01.21
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2021
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 2, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Access
• Arterial Occlusive Diseases
• Coronary Angiography
• Radial Artery Occlusion

Intervention

Device:
• GlideSheath Slender 5Fr arterial sheath
Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
• Conventional 5Fr arterial sheath
Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful hemostasis at 30 minutes after sheath removal		At 30 minutes after sheath removal
Secondary	Crossover rate to conventional radial access		During the procedure
Secondary	Pain associated with the procedure (visual analog scale, VAS)	0-10, 0: no pain, 10: worst pain possible	During the procedure
Secondary	Rate of hematoma modified EASY class=II		Up to 24 hours after hemostatic device removal
Secondary	Rate of forearm radial artery occlusion		7-10 days after the coronary angiography
Secondary	Rate of distal radial artery occlusion		7-10 days after the coronary angiography
Secondary	Rate of fistula formation		7-10 days after the coronary angiography
Secondary	Rate of pseudoaneurysm formation		7-10 days after the coronary angiography