Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Not Applicable

Recruiting

• Conditions: Primary PCI; Distal Transradial Artery; Coronary Catheterization; Percutaneous Coronary Intervention; ST Elevation Myocardial Infarction; Coronary Artery Disease; Transradial Artery
• Interventions: Procedure: Coronary angiography +/- percutaneous coronary intervention

• Registration Number: NCT05605288
• Lead Sponsor: University Hospital of Patras

Brief Summary

Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Detailed Description

Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-04
• Status Verified: 2024-05
• Study Start: 2024-05-23
• Last Update Submitted: 2024-05-25
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

• Age > 18 years old
• Indication: ST-Elevation Myocardial Infraction

Exclusion Criteria

• Non-palpable radial artery
• Previous CABG
• Anatomical restrictions for forearm approach
• Hemodynamic instability
• Previous radial artery catheterization from the same arm during the last 30-days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal transradial artery access	Coronary angiography +/- percutaneous coronary intervention	Vascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions
Conventional transradial artery access	Coronary angiography +/- percutaneous coronary intervention	Vascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions

Primary Outcome Measures

Name	Time	Method
needle-to-wire time	Immediately post-procedurally	needle-to-wire time

Secondary Outcome Measures

Name	Time	Method
Required time percutaneous coronary intervention completion	Immediately post-procedurally	Required time percutaneous coronary intervention completion
Access site crossover rate	Immediately post-procedurally	Crossover rate from distal transradial artery access to other access point
Required time for coronary angiography completion, after sheath insertion	Immediately post-procedurally	Required time for coronary angiography completion, after sheath insertion
Air Kerma	Immediately post-procedurally	Air Kerma
Vascular complications	24 hours	Vascular complications
30-days Clinical follow-up (on site or via telephone call)	30 days	30-days Clinical follow-up (on site or via telephone call)
Radial artery occlusion using Doppler examination prior to hospital discharge	The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI	Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation
Sheath insertion time	Immediately post-procedurally	Duration required from the beginning of puncture until sheath insertion
Total procedure time	Immediately post-procedurally	Total duration of coronary angiography and angioplasty
The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI	Immediately post-procedurally	The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI
Total fluoroscopy time	Immediately post-procedurally	Total fluoroscopy time
Total Dose Area Product (DAP)	Immediately post-procedurally	Total Dose Area Product (DAP)
Hemostasis time	3 hours	Time required for achieving hemostasis
Hematomas classification (modified EASY classification)	24 hours	Hematomas classification using modified EASY which is compatible with dTRA

Trial Locations

Locations (3)

Department of Cardiology, Centre Hospitalier Universitaire de Charleroi; 🇧🇪 Charleroi, Belgium

Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.; 🇨🇭 Geneva, Switzerland

University Hospital of Patras; 🇬🇷 Patras, Greece