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Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Primary Purpose

Coronary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronary Angiography and Intervention
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Distal radial artery, Radial access

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is over 18 years of age.
  • Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
  • Patient has provided written informed consent.
  • Patient is willing to comply with all protocol-required evaluations during the hospitalization.

Exclusion Criteria:

  • No palpable radial artery or distal radial artery.
  • Radial artery used as a bridging vessel.
  • Severe heart failure (NYHA class IV).
  • Severe renal insufficiency ( SCr>443umol/L).
  • Height over 185 cm.
  • A ≥7F catheter may be required for operation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    dTRA group

    cTRA group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Radial artery occlusion
    Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2021
    Last Updated
    April 8, 2021
    Sponsor
    Beijing Anzhen Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04784078
    Brief Title
    Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
    Official Title
    Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 10, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Anzhen Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner. It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time. Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Disease
    Keywords
    Distal radial artery, Radial access

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    dTRA group
    Arm Type
    Experimental
    Arm Title
    cTRA group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Coronary Angiography and Intervention
    Intervention Description
    Transradial access puncture site
    Primary Outcome Measure Information:
    Title
    Radial artery occlusion
    Description
    Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
    Time Frame
    Within 24 hours after the procedure.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is over 18 years of age. Patient is undergoing diagnostic coronary angiography and/or PCI for the first time. Patient has provided written informed consent. Patient is willing to comply with all protocol-required evaluations during the hospitalization. Exclusion Criteria: No palpable radial artery or distal radial artery. Radial artery used as a bridging vessel. Severe heart failure (NYHA class IV). Severe renal insufficiency ( SCr>443umol/L). Height over 185 cm. A ≥7F catheter may be required for operation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lixia Yang, Doctor
    Phone
    13661339066
    Email
    ylx966@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yujie Zhou, Doctor
    Organizational Affiliation
    Beijing Anzhen Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32553614
    Citation
    Nikolakopoulos I, Vemmou E, Brilakis ES. Distal radial access for cardiac catheterization: When and how. Hellenic J Cardiol. 2020 Mar-Apr;61(2):110-111. doi: 10.1016/j.hjc.2020.06.001. Epub 2020 Jun 14. No abstract available.
    Results Reference
    background
    PubMed Identifier
    31227393
    Citation
    Liontou C, Kontopodis E, Oikonomidis N, Maniotis C, Tassopoulos A, Tsiafoutis I, Lazaris E, Koutouzis M. Distal Radial Access: A Review Article. Cardiovasc Revasc Med. 2020 Mar;21(3):412-416. doi: 10.1016/j.carrev.2019.06.003. Epub 2019 Jun 8.
    Results Reference
    result
    PubMed Identifier
    30336816
    Citation
    Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.
    Results Reference
    result
    PubMed Identifier
    30314833
    Citation
    Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2.
    Results Reference
    result
    PubMed Identifier
    31675155
    Citation
    Xenogiannis I, Brilakis ES. Distal radial access at the anatomic snuffbox: The new standard for left radial access? Catheter Cardiovasc Interv. 2019 Nov 1;94(5):658-659. doi: 10.1002/ccd.28551. No abstract available.
    Results Reference
    result

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    Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

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