ClinicalTrials.gg
RecruitingNCT07617259US-DRASTICUpdated Jun 1, 2026

UltraSound Guided Distal Radial Artery vS Conventional Transradial Access for Interventional Coronary Angiography

An interventional study of coronary angiography in Radial Artery Access and Distal Radial Artery Access (dTRA), sponsored by University Hospital of Patras. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital of Patras · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Comparative study of ultrasound-guided distal radial access versus conventional radial access regarding the incidence of vascular access crossover.

Read the 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
02

Conditions studied

  • Radial Artery Access
  • Distal Radial Artery Access (dTRA)

Keywords

  • distal radial artery
  • dra
  • coronary
  • ultrasound
  • distal
  • dtra
  • u/s
  • ultrasound guided
  • ICA
  • coronary angiography
03

In context

Lead sponsor

University Hospital of Patras is the lead sponsor of 43 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Indication for Invasive coronary angiography

Exclusion criteria

Exclusion Criteria:

  • STEMI
  • Renal replacement therapy patients
  • Serious dermal or bone deformity of the radiocarpal joint
  • Shock
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
1,400 participants (estimated)

Study arms

  • Active comparator
    ultrasound guided distal radial artery

    ultrasound guided distal radial artery acess for coronary angiography

    Procedure: coronary angiography

  • Active comparator
    ultrasound guided conventional transradial acess

    ultrasound guided conventional transradial acess for coronary angiography

    Procedure: coronary angiography

Interventions

  • Procedurecoronary angiography

    Diagnostic and if indicated percutaneus coronary intervention during coronary angiography

    Also known as: pci

06

What researchers measure

Primary outcomes

  1. crossover

    Need for a different access to begin the procedure other than the one specified in the patient's arm

    Time frame: Periprocedural.Up to 5 mins will be allowed before giving up on designated method to obtain access

Secondary outcomes

  1. Arterial vasospasm

    Time frame: periprocedural

  2. hemostasis

    Time from procedure's end until removal of hemostatic device

    Time frame: Will be checked at set intervals of 30-60-90-180 mins post procedure

  3. Time until pci

    Time from first needle puncture until pci (percutaneous coronary intervention) has been completed (If needed)

    Time frame: periprocedural

  4. radial artery occlusion

    ultrasound evaluation of radial artery patency after end of hemostasis

    Time frame: 30 days post procedure

  5. hematoma

    using EASY classification

    Time frame: pre discharge , post procedure

  6. Time required for sheath insertion

    Time required from first puncture until sheath is sucessfully introduced into the artery

    Time frame: periprocedural

  7. Total procedure time

    Time from first needle puncture until procedure end (hemostatic device placement signals the end )

    Time frame: periprocedural

  8. Coronary angiography time

    Time from first needle puncture until all 3 coronary arteries have been sufficiently depicted

    Time frame: periprocedural

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Mori S, Hirano K, Yamawaki M, Kobayashi N, Sakamoto Y, Tsutsumi M, Honda Y, Makino K, Shirai S, Ito Y. A Comparative Analysis between Ultrasound-Guided and Conventional Distal Transradial Access for Coronary Angiography and Intervention. J Interv Cardiol. 2020 Sep 8;2020:7342732. doi: 10.1155/2020/7342732. eCollection 2020. PubMed 32982609 ↗
  • Moussa Pacha H, Alahdab F, Al-Khadra Y, Idris A, Rabbat F, Darmoch F, Soud M, Zaitoun A, Kaki A, Rao SV, Kwok CS, Mamas MA, Alraies MC. Ultrasound-guided versus palpation-guided radial artery catheterization in adult population: A systematic review and meta-analysis of randomized controlled trials. Am Heart J. 2018 Oct;204:1-8. doi: 10.1016/j.ahj.2018.06.007. Epub 2018 Jun 19. PubMed 30077047 ↗
  • Ferrante G, Condello F, Rao SV, Maurina M, Jolly S, Stefanini GG, Reimers B, Condorelli G, Lefevre T, Pancholy SB, Bertrand O, Valgimigli M. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2297-2311. doi: 10.1016/j.jcin.2022.09.006. PubMed 36423974 ↗
  • Hamandi M, Saad M, Hasan R, Megaly M, Abbott JD, Dib C, Szerlip M, Potluri S, Lotfi A, Kiemeneij F, Al-Azizi KM. Distal Versus Conventional Transradial Artery Access for Coronary Angiography and Intervention: A Meta-Analysis. Cardiovasc Revasc Med. 2020 Oct;21(10):1209-1213. doi: 10.1016/j.carrev.2020.03.020. Epub 2020 Mar 14. PubMed 32321695 ↗
  • Feng C, Zong B, Liu Y, Chen M, Li S, Xu D, Han B. Comparison of distal transradial approach versus conventional transradial approach for coronary angiography and percutaneous coronary intervention: A prospective observational study. Heliyon. 2023 Jun 14;9(6):e17150. doi: 10.1016/j.heliyon.2023.e17150. eCollection 2023 Jun. PubMed 37360091 ↗
  • Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7. PubMed 38331793 ↗
  • Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17. PubMed 35595673 ↗
  • Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013. PubMed 33602433 ↗
  • Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2. PubMed 30314833 ↗
  • Roh JH, Lee JH. Distal Radial Approach through the Anatomical Snuff Box for Coronary Angiography and Percutaneous Coronary Intervention. Korean Circ J. 2018 Dec;48(12):1131-1134. doi: 10.4070/kcj.2018.0293. No abstract available. PubMed 30403016 ↗
  • Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15. PubMed 34922888 ↗
  • Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686. PubMed 26811162 ↗
  • Valgimigli M, Landi A. Distal Transradial Access for Coronary Procedures: Old Certainties, Novel Challenges, and Future Horizons. JACC Cardiovasc Interv. 2022 Jan 10;15(1):33-38. doi: 10.1016/j.jcin.2021.10.032. Epub 2021 Dec 15. No abstract available. PubMed 34922887 ↗
  • Shroff AR, Gulati R, Drachman DE, Feldman DN, Gilchrist IC, Kaul P, Lata K, Pancholy SB, Panetta CJ, Seto AH, Speiser B, Steinberg DH, Vidovich MI, Woody WW, Rao SV. SCAI expert consensus statement update on best practices for transradial angiography and intervention. Catheter Cardiovasc Interv. 2020 Feb;95(2):245-252. doi: 10.1002/ccd.28672. Epub 2019 Dec 27. PubMed 31880380 ↗
  • Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018 Sep;11(9):e000035. doi: 10.1161/HCV.0000000000000035. PubMed 30354598 ↗
  • Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available. PubMed 30165437 ↗

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07617259
Lead sponsor
University Hospital of Patras
Responsible party
Grigorios Tsigkas (Tsigas Grigorios pHD,Assistant proffessor of cardiology at University Hospital of Patras, University Hospital of Patras) — Principal investigator
First posted
Jun 1, 2026
Start date
May 12, 2026
Primary completion
May 12, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Jun 1, 2026

Study contacts

Athinagoras Theofilatos
Contact
athinag@gmail.com
+30 6946747300
Grigorios Tsigas, assistant professor
Contact
+30 6974466662

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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