Feasibility and Safety of the Routine Distal Transradial Approach

NCT05982366 | Completed

• 1 other identifier: AntaresStudy01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

radial artery; distal transradial approach; access complication; anatomical snuffbox

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• efficacy endpoint: rate of access crossover

  during the procedure index

• safety endpoint: patients' discomfort evaluated during access performance

  during the procedure

• efficacy endpoint: duration of access performance

  during the procedure index

• safety endpoint: access-site vascular complications

  after 24 hours post procedure

Other Outcomes (3)

• Access-time

  during procedure

• radial artery size

  before the procedure, 24 hours and 60 days after the procedure

• radial artery velocity

  before the procedure, 24 hours and 60 days after the procedure

Study Arms (2)

Distal transradial approach

EXPERIMENTAL

Distal transradial approach as the default strategy

Other: distal radial artery acess side

Conventional transradial approach

ACTIVE COMPARATOR

Conventional transradial approach as the default strategy

Other: conventional radial artery acess side

Interventions

distal radial artery acess side OTHER

coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area

Also known as: dTRA

Distal transradial approach

conventional radial artery acess side OTHER

coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area

Also known as: cTRA

Conventional transradial approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients referred for CAG and/or PCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Łukasz Koziński: lead

Study Sites (1)

Szpital Specjalistyczny

Chojnice, Pomeranian, 89-600, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Łukasz Koziński, MD

  Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński

Model Details: Prospective, single-center, randomized trial

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: August 8, 2023
• Study Start: November 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: May 31, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)