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NCT05605288 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— DR-STEMI  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05605288
Other study ID # 26150/30.09.22
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2023
Est. completion date April 2024

Study information
Verified date September 2023
Source University Hospital of Patras
Contact Grigorios Tsigkas, MD, PhD
Phone +306974466662
Email gregtsig@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 554
Est. completion date April 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Coronary angiography +/- percutaneous coronary intervention
Coronary angiography +/- percutaneous coronary intervention

Locations
Country Name City State
Belgium Department of Cardiology, Centre Hospitalier Universitaire de Charleroi Charleroi
Greece University Hospital of Patras Patras
Switzerland Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland. Geneva

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Patras

Countries where clinical trial is conducted

Belgium,  Greece,  Switzerland, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary needle-to-wire time needle-to-wire time Immediately post-procedurally
Secondary 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 The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI
Secondary Access site crossover rate Crossover rate from distal transradial artery access to other access point Immediately post-procedurally
Secondary Sheath insertion time Duration required from the beginning of puncture until sheath insertion Immediately post-procedurally
Secondary Total procedure time Total duration of coronary angiography and angioplasty Immediately post-procedurally
Secondary 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 Immediately post-procedurally
Secondary Required time for coronary angiography completion, after sheath insertion Required time for coronary angiography completion, after sheath insertion Immediately post-procedurally
Secondary Required time percutaneous coronary intervention completion Required time percutaneous coronary intervention completion Immediately post-procedurally
Secondary Total fluoroscopy time Total fluoroscopy time Immediately post-procedurally
Secondary Total Dose Area Product (DAP) Total Dose Area Product (DAP) Immediately post-procedurally
Secondary Air Kerma Air Kerma Immediately post-procedurally
Secondary Hemostasis time Time required for achieving hemostasis 3 hours
Secondary Vascular complications Vascular complications 24 hours
Secondary Hematomas classification (modified EASY classification) Hematomas classification using modified EASY which is compatible with dTRA 24 hours
Secondary 30-days Clinical follow-up (on site or via telephone call) 30-days Clinical follow-up (on site or via telephone call) 30 days
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