AzTrials
AzTrials

ST Elevation Myocardial InfarctionDR-STEMINCT05605288

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

A study testing Coronary angiography +/- percutaneous coronary intervention in people with ST Elevation Myocardial Infarction and Coronary Artery Disease, run by University Hospital of Patras at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary angiography +/- percutaneous coronary intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
3 sitesin 3 countries
Study dates
23 May 2024to 30 Jun 2026
Phase
Interventional
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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Belgium1 site
  • Department of Cardiology, Centre Hospitalier Universitaire de Charleroi

    Charleroi

Other trials in Belgium

Greece1 site
  • University Hospital of Patras

    Pátrai, 26500

Other trials in Greece

Switzerland1 site
  • Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.

    Geneva

Other trials in Switzerland

About this study

Official title: Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With ST-elevation Myocardial Infraction (STEMI): The DR-STEMI Trial

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.

Read the detailed description

Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. 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). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). 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.

Being tested
Coronary angiography +/- percutaneous coronary intervention
Keywords
ST Elevation Myocardial Infarction, Coronary Artery Disease, distal transradial artery, transradial artery, coronary catheterization, percutaneous coronary intervention, primary PCI
Medical subject headings
ST Elevation Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary angiography +/- percutaneous coronary interventionProcedure or surgery

    Coronary angiography +/- percutaneous coronary intervention

Study groups in NCT05605288
Study groupRoleWhat they receive
Distal transradial artery accessExperimentalVascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions
Receives: Procedure: Coronary angiography +/- percutaneous coronary intervention
Conventional transradial artery accessActive comparatorVascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions
Receives: Procedure: Coronary angiography +/- percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. needle-to-wire time

    needle-to-wire time

    Measured: Immediately post-procedurally

Secondary outcomes (14)
  1. Radial artery occlusion using Doppler examination prior to hospital discharge

    Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation

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

  2. Access site crossover rate

    Crossover rate from distal transradial artery access to other access point

    Measured: Immediately post-procedurally

  3. Sheath insertion time

    Duration required from the beginning of puncture until sheath insertion

    Measured: Immediately post-procedurally

  4. Total procedure time

    Total duration of coronary angiography and angioplasty

    Measured: Immediately post-procedurally

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

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

    Measured: Immediately post-procedurally

  6. Required time for coronary angiography completion, after sheath insertion

    Required time for coronary angiography completion, after sheath insertion

    Measured: Immediately post-procedurally

  7. Required time percutaneous coronary intervention completion

    Required time percutaneous coronary intervention completion

    Measured: Immediately post-procedurally

  8. Total fluoroscopy time

    Total fluoroscopy time

    Measured: Immediately post-procedurally

  9. Total Dose Area Product (DAP)

    Total Dose Area Product (DAP)

    Measured: Immediately post-procedurally

  10. Air Kerma

    Air Kerma

    Measured: Immediately post-procedurally

  11. Hemostasis time

    Time required for achieving hemostasis

    Measured: 3 hours

  12. Vascular complications

    Vascular complications

    Measured: 24 hours

  13. Hematomas classification (modified EASY classification)

    Hematomas classification using modified EASY which is compatible with dTRA

    Measured: 24 hours

  14. 30-days Clinical follow-up (on site or via telephone call)

    30-days Clinical follow-up (on site or via telephone call)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start23 May 2024
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605288
Sponsor's protocol ID
26150/30.09.22
Acronym
DR-STEMI
Status last verified
Jul 2026
First submitted
10 Oct 2022
Last updated
6 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32135274
  • 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.

    PubMed 34061817
  • 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.

    PubMed 35595672
  • 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
  • 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
  • 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.

    PubMed 35393114
  • 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
  • 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.

    PubMed 35583362
  • 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.

    PubMed 40816555

Questions about this trial

What is this clinical trial studying?

A study testing Coronary angiography +/- percutaneous coronary intervention in people with ST Elevation Myocardial Infarction and Coronary Artery Disease, run by University Hospital of Patras at 3 sites in 3 countries.

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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Greece, Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

needle-to-wire time (time frame: Immediately post-procedurally). 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 NCT05605288, which also lists 9 linked publications.

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 6 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in