Feasibility and Safety of the Routine Distal Transradial Approach

Coronary Artery Disease Clinical Trial

— ANTARES  

Official title:

distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05982366
• Other study ID #: AntaresStudy01
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Indywidualna Praktyka Lekarska Lekarz Lukasz Kozinski
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.

Description:

Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and elective coronary procedures. The advantages of TRA compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial Access for coRonary procEdures Study) was to assess the feasibility, safety and various ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial. There are two arms: distal transradial access and conventional transradial approach.

400 patients were enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients referred for CAG and/or PCI

Exclusion Criteria:

• ST-elevation myocardial infarction

• sudden cardiac arrest

• hemody-namic instability

• chronic kidney disease (stages 4-5)

• forearm artery occlusion

• previous unsuccessful ipsilateral TRA

• unfavorable RA diameter

• ultrasound unavailability

Related Conditions & MeSH terms

• Coronary Angiography
• Coronary Artery Disease
• Puncture
• Radial Artery
• Vascular Access Complication

Intervention

Other:
• distal radial artery acess side
coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area
• conventional radial artery acess side
coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area

Locations

Country	Name	City	State
Poland	Szpital Specjalistyczny	Chojnice	Pomeranian

Sponsors (1)

Lead Sponsor	Collaborator
Lukasz Kozinski

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Access-time	counted from local anesthesia to successful insertion of the sheath	during procedure
Other	radial artery size	parameter measured by Doppler Ultrasound at the access point	before the procedure, 24 hours and 60 days after the procedure
Other	radial artery velocity	parameter measured by Doppler Ultrasound at the access point	before the procedure, 24 hours and 60 days after the procedure
Primary	The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.	Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.; Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm).; MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.	up to 24 hours
Secondary	efficacy endpoint: rate of access crossover	Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.	during the procedure index
Secondary	safety endpoint: patients' discomfort evaluated during access performance	physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort)	during the procedure
Secondary	efficacy endpoint: duration of access performance	(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)	during the procedure index
Secondary	safety endpoint: access-site vascular complications	it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound	after 24 hours post procedure