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Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI (DR-STEMI)

Primary Purpose

ST Elevation Myocardial Infarction, Coronary Artery Disease, Distal Transradial Artery

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Coronary angiography +/- percutaneous coronary intervention
Sponsored by
University Hospital of Patras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring ST Elevation Myocardial Infarction, Coronary Artery Disease, distal transradial artery, transradial artery, coronary catheterization, percutaneous coronary intervention, primary PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology, Centre Hospitalier Universitaire de Charleroi
  • University Hospital of Patras
  • Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal transradial artery access

Conventional transradial artery access

Arm Description

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

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

Outcomes

Primary Outcome Measures

needle-to-wire time
needle-to-wire time

Secondary Outcome Measures

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
Access site crossover rate
Crossover rate from distal transradial artery access to other access point
Sheath insertion time
Duration required from the beginning of puncture until sheath insertion
Total procedure time
Total duration of coronary angiography and angioplasty
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
Required time for coronary angiography completion, after sheath insertion
Required time for coronary angiography completion, after sheath insertion
Required time percutaneous coronary intervention completion
Required time percutaneous coronary intervention completion
Total fluoroscopy time
Total fluoroscopy time
Total Dose Area Product (DAP)
Total Dose Area Product (DAP)
Air Kerma
Air Kerma
Hemostasis time
Time required for achieving hemostasis
Vascular complications
Vascular complications
Hematomas classification (modified EASY classification)
Hematomas classification using modified EASY which is compatible with dTRA
30-days Clinical follow-up (on site or via telephone call)
30-days Clinical follow-up (on site or via telephone call)

Full Information

First Posted
October 10, 2022
Last Updated
September 7, 2023
Sponsor
University Hospital of Patras
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1. Study Identification

Unique Protocol Identification Number
NCT05605288
Brief Title
Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction, Coronary Artery Disease, Distal Transradial Artery, Transradial Artery, Coronary Catheterization, Percutaneous Coronary Intervention, Primary PCI
Keywords
ST Elevation Myocardial Infarction, Coronary Artery Disease, distal transradial artery, transradial artery, coronary catheterization, percutaneous coronary intervention, primary PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
554 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distal transradial artery access
Arm Type
Experimental
Arm Description
Vascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions
Arm Title
Conventional transradial artery access
Arm Type
Active Comparator
Arm Description
Vascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions
Intervention Type
Procedure
Intervention Name(s)
Coronary angiography +/- percutaneous coronary intervention
Intervention Description
Coronary angiography +/- percutaneous coronary intervention
Primary Outcome Measure Information:
Title
needle-to-wire time
Description
needle-to-wire time
Time Frame
Immediately post-procedurally
Secondary Outcome Measure Information:
Title
Radial artery occlusion using Doppler examination prior to hospital discharge
Description
Radial artery patency evaluation with Doppler ultrasound prior to hospital discharge for detecting possible occlusion after cannulation
Time Frame
The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI
Title
Access site crossover rate
Description
Crossover rate from distal transradial artery access to other access point
Time Frame
Immediately post-procedurally
Title
Sheath insertion time
Description
Duration required from the beginning of puncture until sheath insertion
Time Frame
Immediately post-procedurally
Title
Total procedure time
Description
Total duration of coronary angiography and angioplasty
Time Frame
Immediately post-procedurally
Title
The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI
Description
The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI
Time Frame
Immediately post-procedurally
Title
Required time for coronary angiography completion, after sheath insertion
Description
Required time for coronary angiography completion, after sheath insertion
Time Frame
Immediately post-procedurally
Title
Required time percutaneous coronary intervention completion
Description
Required time percutaneous coronary intervention completion
Time Frame
Immediately post-procedurally
Title
Total fluoroscopy time
Description
Total fluoroscopy time
Time Frame
Immediately post-procedurally
Title
Total Dose Area Product (DAP)
Description
Total Dose Area Product (DAP)
Time Frame
Immediately post-procedurally
Title
Air Kerma
Description
Air Kerma
Time Frame
Immediately post-procedurally
Title
Hemostasis time
Description
Time required for achieving hemostasis
Time Frame
3 hours
Title
Vascular complications
Description
Vascular complications
Time Frame
24 hours
Title
Hematomas classification (modified EASY classification)
Description
Hematomas classification using modified EASY which is compatible with dTRA
Time Frame
24 hours
Title
30-days Clinical follow-up (on site or via telephone call)
Description
30-days Clinical follow-up (on site or via telephone call)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grigorios Tsigkas, MD, PhD
Phone
+306974466662
Email
gregtsig@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adel Aminian, MD, PhD
Email
adaminian@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grigorios Tsigkas, MD, PhD
Organizational Affiliation
University Hospital of Patras
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adel Aminian, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Charleroi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Inglesias, MD, PhD
Organizational Affiliation
Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Centre Hospitalier Universitaire de Charleroi
City
Charleroi
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adel Aminian, MD,PhD
Email
adaminian@hotmail.com
Facility Name
University Hospital of Patras
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grigorios Tsigkas, MD,PhD
Email
gregtsig@hotmail.com
Facility Name
Department of Cardiology, Geneva University Hospitals, Geneva, Switzerland.
City
Geneva
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan F Inglesias, MD
Phone
41793474849
Email
Juanfernando.Iglesias@hcuge.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32135274
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.
Results Reference
background
PubMed Identifier
34061817
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.
Results Reference
background
PubMed Identifier
35595672
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.
Results Reference
background
PubMed Identifier
33602433
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.
Results Reference
background
PubMed Identifier
34922888
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.
Results Reference
background
PubMed Identifier
35393114
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.
Results Reference
background
PubMed Identifier
35595673
Citation
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.
Results Reference
background
PubMed Identifier
35583362
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.
Results Reference
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Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

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