NCT05605288

Brief Summary

Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

Trial Health

60
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
554

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
3 countries

3 active sites

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

First Submitted

Initial submission to the registry

October 10, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 23, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

October 10, 2022

Last Update Submit

May 25, 2024

Conditions

Keywords

ST Elevation Myocardial InfarctionCoronary Artery Diseasedistal transradial arterytransradial arterycoronary catheterizationpercutaneous coronary interventionprimary PCI

Outcome Measures

Primary Outcomes (1)

  • needle-to-wire time

    needle-to-wire time

    Immediately post-procedurally

Secondary Outcomes (14)

  • Radial artery occlusion using Doppler examination prior to hospital discharge

    The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI

  • Access site crossover rate

    Immediately post-procedurally

  • Sheath insertion time

    Immediately post-procedurally

  • Total procedure time

    Immediately post-procedurally

  • The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI

    Immediately post-procedurally

  • +9 more secondary outcomes

Study Arms (2)

Distal transradial artery access

EXPERIMENTAL

Vascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions

Procedure: Coronary angiography +/- percutaneous coronary intervention

Conventional transradial artery access

ACTIVE COMPARATOR

Vascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions

Procedure: Coronary angiography +/- percutaneous coronary intervention

Interventions

Coronary angiography +/- percutaneous coronary intervention

Conventional transradial artery accessDistal transradial artery access

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years old
  • Indication: ST-Elevation Myocardial Infraction

You may not qualify if:

  • Non-palpable radial artery
  • Previous CABG
  • Anatomical restrictions for forearm approach
  • Hemodynamic instability
  • Previous radial artery catheterization from the same arm during the last 30-days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Cardiology, Centre Hospitalier Universitaire de Charleroi

Charleroi, Belgium

RECRUITING

University Hospital of Patras

Pátrai, 26500, Greece

RECRUITING

Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.

Geneva, Switzerland

RECRUITING

Related Publications (9)

  • Tsigkas G, Moulias A, Papageorgiou A, Ntouvas I, Grapsas N, Despotopoulos S, Apostolos A, Papanikolaou A, Smaili K, Vasilagkos G, Davlouros P, Hahalis G. Transradial access through the anatomical snuffbox: Results of a feasibility study. Hellenic J Cardiol. 2021 May-Jun;62(3):201-205. doi: 10.1016/j.hjc.2020.02.002. Epub 2020 Mar 2.

    PMID: 32135274BACKGROUND
  • Didagelos M, McEntegart M, Kouparanis A, Tsigkas G, Koutouzis M, Tsiafoutis I, Kassimis G, Oldroyd KG, Ziakas A. Distal Transradial (Snuffbox) Access for Coronary Catheterization: A Systematic Review. Cardiol Rev. 2021 Jul-Aug 01;29(4):210-216. doi: 10.1097/CRD.0000000000000339.

    PMID: 34061817BACKGROUND
  • Sgueglia GA, Hassan A, Harb S, Ford TJ, Koliastasis L, Milkas A, Zappi DM, Navarro Lecaro A, Ionescu E, Rankin S, Said CF, Kuiper B, Kiemeneij F. International Hand Function Study Following Distal Radial Access: The RATATOUILLE Study. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1205-1215. doi: 10.1016/j.jcin.2022.04.023. Epub 2022 May 17.

    PMID: 35595672BACKGROUND
  • 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
  • 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
  • Tsigkas G, Papageorgiou A, Moulias A, Apostolos A, Kalogeropoulos AP, Davlouros P. Reply: Distal Transradial Access for Primary PCI in ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2022 Apr 11;15(7):795-796. doi: 10.1016/j.jcin.2022.02.039. No abstract available.

    PMID: 35393114BACKGROUND
  • 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
  • Tsigkas G, Apostolos A, Davlouros P. Less Is More, But Not Always: Distal Transradial Access for Radial Artery Occlusion Prevention. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1202-1204. doi: 10.1016/j.jcin.2022.05.001. Epub 2022 May 17. No abstract available.

    PMID: 35583362BACKGROUND
  • Tsigkas G, Trigka-Vasilakopoulou A, Apostolos A, Papafaklis M, Colletti G, Mugnolo A, Ruzsa Z, Ungureanu C, Nikas D, Xaplanteris P, Gasparini GL, Sciahbasi A, Tsiafoutis I, Poulimenos LE, Didagelos M, Pappas L, Stougiannos P, Hamilos M, Ziakas A, Timpilis F, Karanasos A, Moulias A, Sgueglia GA, Aminian A, Iglesias JF, Michalis L, Davlouros P. Distal versus conventional transradial artery access for coronary catheterization in patients with STEMI (DR-STEMI): Rationale and design of an international, multicenter, randomized trial. Am Heart J. 2026 Jan;291:73-80. doi: 10.1016/j.ahj.2025.08.007. Epub 2025 Aug 13.

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Grigorios Tsigkas, MD, PhD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR
  • Adel Aminian, MD, PhD

    Centre Hospitalier Universitaire de Charleroi

    PRINCIPAL INVESTIGATOR
  • Juan Inglesias, MD, PhD

    Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grigorios Tsigkas, MD, PhD

CONTACT

Adel Aminian, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Cardiology

Study Record Dates

First Submitted

October 10, 2022

First Posted

November 4, 2022

Study Start

May 23, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations