An observational study in Vascular Access Complication, Coronary Artery Disease and STEMI, sponsored by Hospital Arnau de Vilanova. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-11.
Sponsored by Hospital Arnau de Vilanova · Observational
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:
Introduction In recent decades, trans radial access (TRA) through the proximal radial artery has become the standard access site for performing diagnostic and therapeutic coronary procedures, its advantages over trans femoral access being demonstrated through multiple studies. such as reduction in access site complications and even reduction in mortality, especially in higher-risk patients.
There are circumstances in which anatomical variants can limit the clinical benefits of TRA, generating complications such as radial artery occlusion (RAO), which is by far the most frequent complication of this access, with a higher incidence at 24 h and recanalization after 30 days in 50% of patients. The presence of RAO limits access to future procedures, if necessary. The incidence of RAO reported in experienced centers remains high.
Distal Radial Access (DRA) through the anatomical snuffbox of the hand is a technique that has emerged in recent years and has been consolidated in multiple multicenter studies and meta-analyses to obtain arterial access in patients undergoing coronary angiography. and coronary intervention, which reduces the incidence of RAO, in addition to reducing hemostasis times, favoring patient and operator comfort compared to TRA.
DRA requires a slightly higher learning curve than TRA due to certain anatomical characteristics, such as the size of the distal radial artery, its depth, the presence of tortuosities, and the specific anatomical structures surrounding it. The DRA technique initially described was based on anatomical references (conventional puncture), however, the introduction of ultrasound as a puncture tool allows the operator to identify the size and course of the artery, in addition to a better assessment of the anatomy of the artery. area, thus avoiding injuries to them.
Most of the registries and clinical trials conducted to date are single centers, so the conduct of collaborative studies is of interest to determine the usefulness of different types of arterial access in coronary procedures.
OBJECTIVES Compare the clinical and procedural characteristics of patients undergoing diagnostic or therapeutic coronary procedures using DRA.
PRIMARY OBJECTIVE
SECONDARY OBJECTIVES
STUDY DESIGN Prospective cohort of patients undergoing diagnostic or therapeutic coronary intervention, performed at the University Hospital Arnau de Vilanova in Lleida and open to other centers.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Hospital Arnau de Vilanova is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort of patients who underwent diagnostic and therapeutic coronary procedures in an all-comer population using DRA between August 2020 and December 2025.
Inclusion criteria:
Exclusion criteria:
Distal radial access for coronary procedures
Also known as: coronary angiography, percutaneous coronary intervention, ultrasound-guided access
Vascular access success
Defined when the introducer sheath can be placed appropriately through the punctured artery.
Time frame: During the vascular access procedure.
Distal radial access time
Begins when the anesthesia needle contacts the skin and ends when the introducer sheath has been properly placed.
Time frame: During the vascular access procedure
Radial artery spasm
When at least two of the following five signs were met or only one of them after administration of a second dose of the spasmolytic agent, depending on the operator: persistent pain in the forearm, painful response to manipulation of the catheter, painful response to sheath withdrawal, difficulty in catheter manipulation after being trapped by the radial artery with considerable resistance to sheath withdrawal.
Time frame: Throughout the procedure
Total procedure time
Was considered from the moment the patient entered the catheterization laboratory until the patient left the catheterization laboratory.
Time frame: Throughout the procedure
Patient comfort during vascular access.
It was evaluated using a visual analog pain scale. It allows for measuring the intensity of the pain described by the patient. It consists of a horizontal line of 10 cm. On the left is the absence or lesser intensity, and on the right is the greatest intensity. The assessment will be mild pain if the patient rates the pain as less than 3, moderate pain if the rating is between 4 and 7, and severe pain if the rating is equal to or greater than 8.
Time frame: Throughout the procedure
Exposure to ionizing radiation
Was assessed using the dose area product (DAP) in Gy.m2
Time frame: At the end of the procedure (up to 5 minutes).
Access-related complications
In-hospital radial artery occlusion was defined as the absence of anterograde flow signal on Doppler color ultrasound (US) distal to the radial artery 1-4 hours after the procedure was completed. The forearm hematoma related to DRA was defined according to the classification "Early discharge after transradial stimulation of the coronary arteries study" (EASY): grade I, \<5cm in diameter; grade II, 5-10 cm in diameter; grade III, \>10cm but distal to the elbow; grade IV that extends above the elbow; and grade V, anywhere with an ischemic threat to the hand. Radial artery dissection, pseudoaneurysms, and arteriovenous fistula were also considered vascular complications related to access.
Time frame: At the end of the procedure (up to 6 hours).
Plan to share: Yes — After anonymization, all data collected during the study could be shared. Data obtained through this study may be provided to qualified researchers with academic interest in cardiovascular diseases. The approval of the request and the execution of all applicable agreements are prerequisites for the sharing of data with the requesting party.
Supporting information: 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.
No publications or documents are linked to this record.
Started Aug 2020 (actual). Primary completion is estimated for Dec 2025, 64 months after the start.
Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 64 months is above that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
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Hospital Arnau de Vilanova