Vascular Access ComplicationDISTALNCT06165406
Distal Radial Access for Coronary Procedures
An observational study of Vascular Access Complication and Coronary Artery Disease, run by Hospital Arnau de Vilanova at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Coronary Artery Disease, STEMI
- What is being tested?
- Distal radial access
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
Kristian Rivera, MD, +34-973248157, psrivera.lleida.ics@gencat.cat
Diego Fernández-Rodríguez, PhD, +34-973248157, dfernandez.lleida.ics@gencat.cat
About this study
Official title: Distal Radial Access for Diagnostic and Interventional Coronary Procedures in an All-comer Population: Observational Registry
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.
Read more
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.
Read the detailed description
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
- Determine the success rate of DRA and measure the incidence of RAO.
SECONDARY OBJECTIVES
- Compare the clinical (such as sex, age, weight, etc.) and anatomical characteristics (size of the proximal and distal radial artery size, depth of the distal radial artery) of patients with DRA.
- Compare the time spent obtaining arterial access using DRA.
- Assess the characteristics of the DRA procedure.
- Assess the usefulness of ultrasound evaluation of the radial artery prior to DRA and US-guided DRA.
- Investigate the predictors of failure for DRA.
- Calculate the incidence of local complications related to DRA, radial spasm, puncture site hematoma, RAO, and presence of pseudoaneurysm of the radial artery.
- Assess the operator's and patient comfort based on access.
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.
- Conditions
- Vascular Access Complication, Coronary Artery Disease, STEMI, Non STEMI, Angina, Unstable, Angina, Stable
- Being tested
- Distal radial access
- Keywords
- distal radial access, coronary procedures, ultrasound guided punction, vascular access, access-related complications, transradial access
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Angina, Stable, Arterial Occlusive Diseases, Hematoma, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal radial accessProcedure or surgery
Also called coronary angiography, percutaneous coronary intervention, ultrasound-guided access
Distal radial access for coronary procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular access success
Defined when the introducer sheath can be placed appropriately through the punctured artery.
Measured: During the vascular access procedure.
Secondary outcomes (6)
Distal radial access time
Begins when the anesthesia needle contacts the skin and ends when the introducer sheath has been properly placed.
Measured: 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.
Measured: Throughout the procedure
Total procedure time
Was considered from the moment the patient entered the catheterization laboratory until the patient left the catheterization laboratory.
Measured: 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.
Measured: Throughout the procedure
Exposure to ionizing radiation
Was assessed using the dose area product (DAP) in Gy.m2
Measured: 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.
Measured: At the end of the procedure (up to 6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Arnau de Vilanova
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Torrecárdenas, Hospital Regional de Malaga, Hospital Universitari de Bellvitge, Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Principal investigator, Kristian Rivera, Hospital Arnau de Vilanova
- Investigators
- Kristian Rivera, MD, Principal investigator, University Hospital Arnau de Vilanova, Lleida Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165406
- Sponsor's protocol ID
- CEIC-2804
- Acronym
- DISTAL
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Rivera K, Fernandez-Rodriguez D, Bullones J, Gorrino S, Casanova-Sandoval J, Garcia-Guimaraes M, Papiol E, Ramirez-Martinez T, Coimbra H, Costa-Mateu J, Tornel-Cerezo M, Sanchez Espino A, Worner F, Ferreiro JL. Optimizing distal radial access: clinical and anatomical predictors of failure from the multicenter DISTAL registry. Coron Artery Dis. 2026 Jun 1;37(4):297-307. doi: 10.1097/MCA.0000000000001599. Epub 2025 Dec 3.
PubMed 41334668
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radial Access for Diagnostic and Interventional Coronary Procedures in an All-comer Population: Observational Registry
- ClinicalTrials.gov ID
- NCT06165406
- Acronym / sponsor ID
- DISTAL / CEIC-2804
- Conditions
- Vascular Access Complication, Coronary Artery Disease, STEMI, Non STEMI, Angina, Unstable, Angina, Stable
- Keywords
- distal radial access, coronary procedures, ultrasound guided punction, vascular access, access-related complications, transradial access
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospital Arnau de VilanovaUniversity, hospital or other
- Collaborators
- Hospital Universitario Torrecárdenas, Hospital Regional de Malaga, Hospital Universitari de Bellvitge, Hospital Universitari Joan XXIII de Tarragona.
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Determine the success rate of DRA and measure the incidence of RAO.
SECONDARY OBJECTIVES
- Compare the clinical (such as sex, age, weight, etc.) and anatomical characteristics (size of the proximal and distal radial artery size, depth of the distal radial artery) of patients with DRA.
- Compare the time spent obtaining arterial access using DRA.
- Assess the characteristics of the DRA procedure.
- Assess the usefulness of ultrasound evaluation of the radial artery prior to DRA and US-guided DRA.
- Investigate the predictors of failure for DRA.
- Calculate the incidence of local complications related to DRA, radial spasm, puncture site hematoma, RAO, and presence of pseudoaneurysm of the radial artery.
- Assess the operator's and patient comfort based on access.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal radial accessAlso: coronary angiography, percutaneous coronary intervention, ultrasound-guided accessDistal radial access for coronary procedures | Procedure or surgery | – |
Primary outcome
Vascular access success
Time frame: During the vascular access procedure.
Defined when the introducer sheath can be placed appropriately through the punctured artery.
6 secondary outcomes
Distal radial access time
Time frame: During the vascular access procedure
Radial artery spasm
Time frame: Throughout the procedure
Total procedure time
Time frame: Throughout the procedure
Patient comfort during vascular access.
Time frame: Throughout the procedure
Exposure to ionizing radiation
Time frame: At the end of the procedure (up to 5 minutes).
Access-related complications
Time frame: At the end of the procedure (up to 6 hours).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 41334668Rivera K, Fernandez-Rodriguez D, Bullones J, Gorrino S, Casanova-Sandoval J, Garcia-Guimaraes M, Papiol E, Ramirez-Martinez T, Coimbra H, Costa-Mateu J, Tornel-Cerezo M, Sanchez Espino A, Worner F, Ferreiro JL. Optimizing distal radial access: clinical and anatomical predictors of failure from the multicenter DISTAL registry. Coron Artery Dis. 2026 Jun 1;37(4):297-307. doi: 10.1097/MCA.0000000000001599. Epub 2025 Dec 3.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Rivera, MD principal investigator
University Hospital Arnau de Vilanova, Lleida Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Access Complication and Coronary Artery Disease, run by Hospital Arnau de Vilanova at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristian Rivera, MD (0034973705354, psrivera.lleida.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular access success (time frame: During the vascular access procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06165406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.