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Trans Radial Versus Transfemoral Route for Coronary Angiography

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transradial
Transfemoral
Sponsored by
Sheri Kashmir Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnostic angiography of coronary vessels, PCI

Exclusion Criteria:

  • Patients with impaired renal function tests.

    • Lack of informed consent.
    • Severe infection.
    • Previous contrast allergy.
    • Severe intrinsic/iatrogenic caogulopathy INR>2.
    • Abnormal modified Allen's test.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Transfemoral

    Transradial

    Arm Description

    in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route.

    Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance.

    Outcomes

    Primary Outcome Measures

    Access time
    Access time for the procedures
    Fluoroscopy time
    measure of radiation exposure
    Procedure time
    time taken to do the full procedure
    hospital stay
    time period the patient stayed in the hospital

    Secondary Outcome Measures

    hematoma
    hematoma development at the site of puncture
    pseudoaneurysm
    local complication at the access site
    bleeding
    at the access site
    Access site failure
    failure to gain access for the procedure

    Full Information

    First Posted
    December 1, 2016
    Last Updated
    December 2, 2016
    Sponsor
    Sheri Kashmir Institute of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02983721
    Brief Title
    Trans Radial Versus Transfemoral Route for Coronary Angiography
    Official Title
    Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    August 2015 (Actual)
    Study Completion Date
    August 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sheri Kashmir Institute of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.
    Detailed Description
    Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly. The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Transfemoral
    Arm Type
    Active Comparator
    Arm Description
    in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route.
    Arm Title
    Transradial
    Arm Type
    Active Comparator
    Arm Description
    Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance.
    Intervention Type
    Procedure
    Intervention Name(s)
    transradial
    Intervention Description
    transradial route for coronary angiography and PCI
    Intervention Type
    Procedure
    Intervention Name(s)
    Transfemoral
    Intervention Description
    transfemoral route for coronary angiography and PCI
    Primary Outcome Measure Information:
    Title
    Access time
    Description
    Access time for the procedures
    Time Frame
    4 years
    Title
    Fluoroscopy time
    Description
    measure of radiation exposure
    Time Frame
    4 years
    Title
    Procedure time
    Description
    time taken to do the full procedure
    Time Frame
    4 years
    Title
    hospital stay
    Description
    time period the patient stayed in the hospital
    Time Frame
    4 years
    Secondary Outcome Measure Information:
    Title
    hematoma
    Description
    hematoma development at the site of puncture
    Time Frame
    4 years
    Title
    pseudoaneurysm
    Description
    local complication at the access site
    Time Frame
    4 years
    Title
    bleeding
    Description
    at the access site
    Time Frame
    4 years
    Title
    Access site failure
    Description
    failure to gain access for the procedure
    Time Frame
    4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnostic angiography of coronary vessels, PCI Exclusion Criteria: Patients with impaired renal function tests. Lack of informed consent. Severe infection. Previous contrast allergy. Severe intrinsic/iatrogenic caogulopathy INR>2. Abnormal modified Allen's test.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fayaz Bhat, MBBS, MD
    Organizational Affiliation
    Ministry of Health, Jammu and Kashmir, India.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    can be shared by email
    Citations:
    PubMed Identifier
    28077091
    Citation
    Bhat FA, Changal KH, Raina H, Tramboo NA, Rather HA. Transradial versus transfemoral approach for coronary angiography and angioplasty - A prospective, randomized comparison. BMC Cardiovasc Disord. 2017 Jan 11;17(1):23. doi: 10.1186/s12872-016-0457-2.
    Results Reference
    derived

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    Trans Radial Versus Transfemoral Route for Coronary Angiography

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