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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04911218
Other study ID # 1762/22.01.21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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