Distal Radial Access for Coronary Procedures

NCT06165406 | Unknown

• 1 other identifier: CEIC-2804
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Distal radial access (DRA) in the anatomical snuffbox (AS) is a relatively novel approach that can be considered an alternative to trans radial access (TRA) for coronary procedures. Several observational and randomized studies have established its feasibility and safety, with evidence of certain advantages over TRA, such as a reduction in hemostasis time, a lower incidence of complications at the puncture site, and a lower incidence of radial artery occlusion (RAO). Notwithstanding that a recent randomized study reported a similar RAO rate between DRA and TRA, several meta-analyzes confirm the advantages of DRA, despite a consistently higher crossover rate. The objective of this observational study is to assess the performance of the procedure and to compare clinical characteristics in an all-comer population undergoing diagnostic or interventional coronary procedures. The main questions it aims to answer are:

• Determine the success rate of DRA and measure the incidence of RAO in an all-comer population undergoing coronary procedures.
• Compare the clinical and anatomical characteristics of patients with DRA for coronary procedures and determine predictors of failure of access.

Conditions

Procedural Blood Vessel Puncture; Vascular Access Complication; Coronary Artery Disease; STEMI; Non STEMI; Angina, Unstable; Angina, Stable; Artery Occlusion; Hematoma; Procedural Pain

Keywords

distal radial access; coronary procedures; ultrasound guided punction; vascular access; access-related complications; transradial access

Outcome Measures

Primary Outcomes (1)

• Vascular access success

  Defined when the introducer sheath can be placed appropriately through the punctured artery.

  During the vascular access procedure.

Secondary Outcomes (6)

• Distal radial access time

  During the vascular access procedure

• Radial artery spasm

  Throughout the procedure

• Total procedure time

  Throughout the procedure

• Patient comfort during vascular access.

  Throughout the procedure

• Exposure to ionizing radiation

  At the end of the procedure (up to 5 minutes).

Interventions

Distal radial access PROCEDURE

Distal radial access for coronary procedures

Also known as: coronary angiography, percutaneous coronary intervention, ultrasound-guided access

Eligibility Criteria

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

Study Population

Cohort of patients who underwent diagnostic and therapeutic coronary procedures in an all-comer population using DRA between August 2020 and December 2025.

You may qualify if:

• Patients who have undergone diagnostic or therapeutic coronary procedures using DRA in any clinical setting.
• Patients over 18 years of age.
• Presence of distal radial pulse.
• The Barbeau test was recommended but not mandatory.

You may not qualify if:

• Previously known allergy to iodinated contrast and inability to receive premedication.
• Absence of distal radial pulse and distal radial artery not feasible by ultrasound.
• Women with the possibility of being pregnant.

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead
• Hospital Universitario Torrecárdenas: collaborator
• Hospital Regional de Malaga: collaborator
• Hospital Universitari de Bellvitge: collaborator
• Hospital Universitari Joan XXIII de Tarragona.: collaborator

Study Sites (1)

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Angina, Unstable; Angina, Stable; Arterial Occlusive Diseases; Hematoma; Pain, Procedural

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Kristian Rivera, MD

  University Hospital Arnau de Vilanova, Lleida Spain.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian Rivera, MD

CONTACT

0034973705354; psrivera.lleida.ics@gencat.cat

Diego Fernández-Rodríguez, PhD

CONTACT

0034973705354; dfernandez.lleida.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 11, 2023
• Study Start: August 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available from the publication of the study until 2 years later.
• Access Criteria: The data will be shared with people interested in distal radial access through the contact email.

Locations

ES (1)