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

NCT ID: NCT05605288

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

554 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ST Elevation Myocardial Infarction Coronary Artery Disease Distal Transradial Artery Transradial Artery Coronary Catheterization Percutaneous Coronary Intervention Primary PCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Distal transradial artery access

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

Group Type EXPERIMENTAL

Coronary angiography +/- percutaneous coronary intervention

Intervention Type PROCEDURE

Coronary angiography +/- percutaneous coronary intervention

Conventional transradial artery access

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

Group Type ACTIVE_COMPARATOR

Coronary angiography +/- percutaneous coronary intervention

Intervention Type PROCEDURE

Coronary angiography +/- percutaneous coronary intervention

Interventions

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Coronary angiography +/- percutaneous coronary intervention

Coronary angiography +/- percutaneous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Patras

OTHER

Sponsor Role lead

Responsible Party

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Grigorios Tsigkas

Assistant Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grigorios Tsigkas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Adel Aminian, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Charleroi

Juan Inglesias, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Cardiology, Centre Hospitalier Universitaire de Charleroi

Charleroi, , Belgium

Site Status RECRUITING

University Hospital of Patras

Pátrai, , Greece

Site Status RECRUITING

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

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Belgium Greece Switzerland

Central Contacts

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Grigorios Tsigkas, MD, PhD

Role: CONTACT

+306974466662

Adel Aminian, MD, PhD

Role: CONTACT

Facility Contacts

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Adel Aminian, MD,PhD

Role: primary

Grigorios Tsigkas, MD,PhD

Role: primary

Juan F Inglesias, MD

Role: primary

41793474849

References

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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.

Reference Type BACKGROUND
PMID: 32135274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34061817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35595672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33602433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34922888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35393114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35595673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35583362 (View on PubMed)

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. 2025 Aug 13;291:73-80. doi: 10.1016/j.ahj.2025.08.007. Online ahead of print.

Reference Type DERIVED
PMID: 40816555 (View on PubMed)

Other Identifiers

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26150/30.09.22

Identifier Type: -

Identifier Source: org_study_id

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