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Distal vs Proximal Radial Approach for Coronary Interventions

Primary Purpose

Coronary Disease, Vascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronary angiography using distal radial artery
coronary angiography using proximal radial artery
Sponsored by
University Hospital "Sestre Milosrdnice"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring coronary disease, snuff box, radial access

Eligibility Criteria

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

Inclusion Criteria:

  • signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse

Exclusion Criteria:

  • hemodynamic instability, critically ill patient, usual coronary angiography contraindication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Angiography performed using distal radial artery

    Angiography performed using proximal radial artery

    Arm Description

    Patients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access

    Patients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access

    Outcomes

    Primary Outcome Measures

    Occlusion of the radial artery
    Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler

    Secondary Outcome Measures

    Full Information

    First Posted
    January 14, 2020
    Last Updated
    January 15, 2020
    Sponsor
    University Hospital "Sestre Milosrdnice"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04232488
    Brief Title
    Distal vs Proximal Radial Approach for Coronary Interventions
    Official Title
    Comparison of the Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach in Coronary Angiography and PCI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital "Sestre Milosrdnice"

    4. Oversight

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

    5. Study Description

    Brief Summary
    The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach
    Detailed Description
    Introduction: The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions, which is particularly suitable for patients with renal disease (for preservation of the radial artery due to the potential formation of AV fistula for dialysis) and progressive coronary disease in order to preserve the radial artery for aortocoronary bypass formation. It is also potentially less likely to develop compartment syndrome and is suitable for patients with reduced forearm mobility. Since wrist immobilization during hemostatic compression is not required, the use of a distal radial approach allows for early mobilization of patients and a shorter duration of compression itself. Aim of the study: To compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach Purpose of the study: to confirm the efficacy of the distal radial approach as equally effective with a lower degree of radial artery occlusion during the follow-up period Research Hypothesis: Patients using a coronary angiography / percutaneous intervention using a distal radial approach had less occlusion of the radial arteries at long-term follow-up, with no significant difference in the features of the angiography / intervention itself (duration of procedure, time to obtain the vascular access, amount of contrast used , time and amount of radiation, procedure success). Study participants: patients undergoing coronary intervention at the Catheterization Laboratory of the Clinic for Cardiovascular Diseases at the Clinical Hospital Center "Sestre milosrdnice", Zagreb Research Methodology and Material: Standard materials and standard methods will be used to perform coronary angiography and percutaneous coronary intervention Research Plan: After signing the informed consent, the study will include 250 patients in the distal transradial approach group, and 500 patients in the proximal radial approach group (control group). The materials, as well as the procedure technique, are standardized; the characteristics of the procedure (duration of the procedure, time of obtaining the arterial access, amount of contrast used, time and amount of radiation, success of the procedure) will be observed and Doppler of the radial artery will be performed on the first following operator-specified control (usually after 3 months of the procedure) to determine the patency of the artery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease, Vascular Diseases
    Keywords
    coronary disease, snuff box, radial access

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    750 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Angiography performed using distal radial artery
    Arm Type
    Experimental
    Arm Description
    Patients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access
    Arm Title
    Angiography performed using proximal radial artery
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access
    Intervention Type
    Procedure
    Intervention Name(s)
    coronary angiography using distal radial artery
    Intervention Description
    Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using distal radial artery ('snuff box'); color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
    Intervention Type
    Procedure
    Intervention Name(s)
    coronary angiography using proximal radial artery
    Intervention Description
    Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using proximal radial artery; color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
    Primary Outcome Measure Information:
    Title
    Occlusion of the radial artery
    Description
    Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse Exclusion Criteria: hemodynamic instability, critically ill patient, usual coronary angiography contraindication
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nikola Kos, MD
    Phone
    +385989638946
    Email
    nikolakos89@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nikola Pavlović, MD, PhD
    Email
    nikolap12@yahoo.com

    12. IPD Sharing Statement

    Learn more about this trial

    Distal vs Proximal Radial Approach for Coronary Interventions

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