UltraSound Guided Distal Radial Artery vS Conventional Transradial Access for Interventional Coronary Angiography (US-DRASTIC)

May 24, 2026 updated by: Grigorios Tsigkas, University Hospital of Patras
Comparative study of ultrasound-guided distal radial access versus conventional radial access regarding the incidence of vascular access crossover.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Current European and American guidelines issued by the European Society of Cardiology (ESC), the American Heart Association (AHA), and the Society for Cardiovascular Angiography and Interventions (SCAI) recommend transradial access (TRA) as the preferred access route for cardiac catheterization in both acute and chronic coronary syndromes, as well as in complex coronary interventions. Compared with transfemoral access, transradial access has demonstrated significant benefits regarding vascular complications, major bleeding, mortality, and earlier mobilization and discharge of patients.

In recent years, access through the distal segment of the radial artery in the anatomical snuffbox has emerged as a technique with highly beneficial characteristics comparable to conventional radial access, while also offering additional advantages. The ANGIE study demonstrated that distal radial access was associated with a statistically significant reduction in radial artery occlusion compared with conventional radial puncture. Puncture of the distal radial artery preserves antegrade blood flow in the forearm during hemostatic compression, thereby reducing the risk of arterial occlusion.

Existing literature Although the benefit of distal radial access in preventing radial artery occlusion has now been established, the same does not apply to crossover incidence, namely the need to change to an alternative vascular access site because the intervention cannot be completed through the initially selected access.

Several studies have shown higher crossover rates with distal radial access compared with conventional radial access. In the study by Koutouzis et al., distal radial access failed more often, with a crossover incidence of 30% versus 2% in the conventional radial group. Similar findings were reported in the DAPRAO study, the ANGIE trial, the DISCO RADIAL trial, the CONDITION trial, and observational studies and meta-analyses. Overall, published evidence consistently suggests that distal radial access is associated with a higher likelihood of crossover than conventional radial access when performed without ultrasound guidance.

Aim and originality of the study A common characteristic of all the above studies is that the comparison between the two access techniques was performed using anatomical guidance rather than ultrasound guidance.

As noted in the SCAI recommendations, failure to catheterize the radial artery is the leading cause of transradial procedural failure. The radial artery is relatively small in diameter, may be calcified, or may present anatomical variations that complicate vascular access. Two-dimensional ultrasound may therefore be a valuable tool for pre-procedural planning and real-time guidance.

A large meta-analysis of 12 studies including 2,432 adults undergoing conventional transradial access under ultrasound guidance showed improved first-pass success rates and reduced access failure rates. Similarly, ultrasound-guided distal radial access significantly increased successful intervention rates in the study by Mori et al. Consequently, the purpose of the present study is to demonstrate ultrasound guidance as a technique capable of increasing successful completion rates for both vascular approaches, while establishing distal radial access as a non-inferior alternative to conventional radial access regarding crossover probability.

Methodology The study will be conducted after approval by the Scientific Council and the Ethics and Deontology Committee of the University General Hospital of Patras.

This is a prospective, randomized, single-center, non-inferiority clinical study that will be carried out in the Hemodynamic Laboratory of the Cardiology Department of the University General Hospital of Patras in collaboration with the Radiology Department.

Study population The control group will undergo coronary angiography through conventional transradial access (TRA). The intervention group will undergo coronary angiography through distal radial access (DRA). Radial artery puncture will be performed exclusively under ultrasound guidance. Patients meeting the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to DRA or TRA.

Arterial access procedure:

The procedure begins with sterilization of both potential puncture sites regardless of randomization group. Conventional radial artery puncture is performed approximately 2-3 cm proximal to the styloid process. In patients randomized to distal transradial access (dTRA), puncture is performed more distally in the anatomical snuffbox at an angle of 30-80 degrees.

The interventional cardiologist uses the ultrasound probe exclusively, covered with a sterile protective sheath, to identify anatomical landmarks, define a safe puncture site, and avoid injury to adjacent structures. Local lidocaine infiltration is then performed under ultrasound guidance. The intravascular position of the needle is confirmed by ultrasound visualization and continuous blood flow.

After successful puncture of the radial artery, a 6 French sheath is inserted using the Seldinger technique. Subsequently, 50 IU/kg unfractionated heparin is administered (100 IU/kg total dose in case of angioplasty), together with nitroglycerin according to standard practice.

Hemostasis procedure After completion of the procedure, a TR band device is used. Hemostasis is assessed at 0,5 ,1, 2, and 3 hours after placement of the device, and if hemostasis is not achieved within this timeframe, manual compression is applied.

Data collection

For all participants, the following will be recorded:

  • Demographic characteristics, cardiovascular risk factors, medical history, and chronic medication
  • Body weight and body mass index (BMI)
  • Reason for catheterization (STEMI, NSTEMI, unstable angina, stable coronary artery disease, suspected coronary artery disease, or valvular disease)
  • Periprocedural antiplatelet or anticoagulant therapy
  • Laboratory tests: Ht, Hgb, PLT, WBC, Urea, Creatinine
  • Allen test and quality of radial artery pulse
  • Total puncture attempts and total time to achieve vascular access
  • Fluoroscopy duration, total angiography time, and contrast volume
  • Number and type of diagnostic catheters used
  • Type of hemostatic device and duration of hemostasis Primary endpoint Need for vascular access crossover due to failed puncture, failed wire or sheath advancement, or inability to complete the procedure through the initial vascular access. The exact reason for crossover will be recorded.

Secondary endpoints

  • Local hematoma classified according to EASY criteria
  • Arterial spasm severity
  • Sheath placement time
  • Total procedural time
  • Time from puncture initiation until completion of coronary angiography before PCI
  • Time required for diagnostic coronary angiography after sheath placement
  • Time required until PCI completion
  • Total fluoroscopy time
  • Total DAP
  • Air Kerma
  • Hemostasis duration
  • Vascular complications (arterial perforation, pseudoaneurysm, arteriovenous fistula)
  • Distal radial artery occlusion before discharge
  • Bleeding events according to BARC classification

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Athinagoras Theofilatos
  • Phone Number: +30 6946747300
  • Email: athinag@gmail.com

Study Contact Backup

  • Name: Grigorios Tsigas, assistant professor
  • Phone Number: +30 6974466662

Study Locations

  • Greece
      • Pátrai, Greece
        • Recruiting
        • University Hospital of Patras
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Indication for Invasive coronary angiography

Exclusion Criteria:

  • STEMI
  • Renal replacement therapy patients
  • Serious dermal or bone deformity of the radiocarpal joint
  • Shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound guided distal radial artery
ultrasound guided distal radial artery acess for coronary angiography
Procedure: coronary angiography
Diagnostic and if indicated percutaneus coronary intervention during coronary angiography
Other Names:
  • pci
Active Comparator: ultrasound guided conventional transradial acess
ultrasound guided conventional transradial acess for coronary angiography
Procedure: coronary angiography
Diagnostic and if indicated percutaneus coronary intervention during coronary angiography
Other Names:
  • pci

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crossover
Time Frame: Periprocedural.Up to 5 mins will be allowed before giving up on designated method to obtain access
Need for a different access to begin the procedure other than the one specified in the patient's arm
Periprocedural.Up to 5 mins will be allowed before giving up on designated method to obtain access

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial vasospasm
Time Frame: periprocedural
periprocedural
hemostasis
Time Frame: Will be checked at set intervals of 30-60-90-180 mins post procedure
Time from procedure's end until removal of hemostatic device
Will be checked at set intervals of 30-60-90-180 mins post procedure
Time until pci
Time Frame: periprocedural
Time from first needle puncture until pci (percutaneous coronary intervention) has been completed (If needed)
periprocedural
radial artery occlusion
Time Frame: 30 days post procedure
ultrasound evaluation of radial artery patency after end of hemostasis
30 days post procedure
hematoma
Time Frame: pre discharge , post procedure
using EASY classification
pre discharge , post procedure
Time required for sheath insertion
Time Frame: periprocedural
Time required from first puncture until sheath is sucessfully introduced into the artery
periprocedural
Total procedure time
Time Frame: periprocedural
Time from first needle puncture until procedure end (hemostatic device placement signals the end )
periprocedural
Coronary angiography time
Time Frame: periprocedural
Time from first needle puncture until all 3 coronary arteries have been sufficiently depicted
periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2026

Primary Completion (Estimated)

May 12, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/22.01.2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We plan to share data with other researchers only if they're formally requested and cited afterwards

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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