NCT07617259

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
May 2026Nov 2028

First Submitted

Initial submission to the registry

May 12, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 12, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 12, 2026

Last Update Submit

May 24, 2026

Conditions

Keywords

distal radial arterydracoronaryultrasounddistaldtrau/sultrasound guidedICAcoronary angiography

Outcome Measures

Primary Outcomes (1)

  • crossover

    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 Outcomes (8)

  • Arterial vasospasm

    periprocedural

  • hemostasis

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

  • Time until pci

    periprocedural

  • radial artery occlusion

    30 days post procedure

  • hematoma

    pre discharge , post procedure

  • +3 more secondary outcomes

Study Arms (2)

ultrasound guided distal radial artery

ACTIVE COMPARATOR

ultrasound guided distal radial artery acess for coronary angiography

Procedure: coronary angiography

ultrasound guided conventional transradial acess

ACTIVE COMPARATOR

ultrasound guided conventional transradial acess for coronary angiography

Procedure: coronary angiography

Interventions

Diagnostic and if indicated percutaneus coronary intervention during coronary angiography

Also known as: pci
ultrasound guided conventional transradial acessultrasound guided distal radial artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for Invasive coronary angiography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, Greece

RECRUITING

Related Publications (16)

  • 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.

    PMID: 32982609BACKGROUND
  • 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.

    PMID: 30077047BACKGROUND
  • 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.

    PMID: 36423974BACKGROUND
  • 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.

    PMID: 32321695BACKGROUND
  • 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.

    PMID: 37360091BACKGROUND
  • 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.

    PMID: 38331793BACKGROUND
  • 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.

    PMID: 35595673BACKGROUND
  • 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.

    PMID: 33602433BACKGROUND
  • 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.

    PMID: 30314833BACKGROUND
  • 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.

    PMID: 30403016BACKGROUND
  • 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.

    PMID: 34922888BACKGROUND
  • 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.

    PMID: 26811162BACKGROUND
  • 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.

    PMID: 34922887BACKGROUND
  • 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.

    PMID: 31880380BACKGROUND
  • 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.

    PMID: 30354598BACKGROUND
  • 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.

    PMID: 30165437BACKGROUND

MeSH Terms

Conditions

Congenital chloride diarrhea

Interventions

alpha 1-Antitrypsin

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesSerpinsPeptidesAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsProteinsAlpha-GlobulinsSerum GlobulinsGlobulins

Central Study Contacts

Athinagoras Theofilatos

CONTACT

Grigorios Tsigas, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tsigas Grigorios pHD,Assistant proffessor of cardiology at University Hospital of Patras

Study Record Dates

First Submitted

May 12, 2026

First Posted

June 1, 2026

Study Start

May 12, 2026

Primary Completion (Estimated)

May 12, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

June 1, 2026

Record last verified: 2026-05

Locations