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NCT Number: NCT04801901

Distal Transradial Access for Percutaneous Coronary Intervention

Prospective randomized non-blinded study to determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA).

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Key information

Conditions

Transradial Access Coronary Angiography Distal Radial Artery Access (dTRA) Radial Artery Intimal Medial Thickness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

About this study

To determine degree of vessel trauma and adverse remodeling of the proximal forearm radial artery, using ultrahigh resolution (55 MHz) ultrasound, following distal radial artery access (dTRA) for cardiac catheterization compared to standard forearm transradial access (fTRA) at 90 days post-procedure. Secondary outcome measures will include metrics of procedural success at 24 hours, as well as functional assessment of pain and motor strength of the ipsilateral upper extremity at 90 days post-procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive patients undergoing elective and non-emergent TR LHC and/or PCI at the INOVA Heart and Vascular Institute
  • Able to provide informed consent.
  • Patients willing to complete a 90day post PCI radial artery ultrasound.

Exclusion criteria

  • Patients with previous cannulation of both the right and left forearm RA's for coronary angiography and/or PCI. In patients with prior cannulation of one RA, the contralateral arm may be used for this study.
  • Patients who are not willing to undergo the necessary follow-up ultrasound examinations.
  • ST elevation myocardial infarction or other emergent PCI
  • Inability to provide informed consent

Treatment and study plan

dTRA

Procedure

Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)

fTRA

Procedure

Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.

Primary outcomes

  1. Radial artery intimal medial thickness following dTRA and fTRA

    Time frame: 90 days post-cardiac catheterization.

    Intimal medial thickness (mm) of the forearm radial artery followed dTRA and fTRA as assessed using ultrahigh resolution 55 MHz ultrasound probe at 90 days post cardiac catheterization.

Secondary outcomes

  1. Radial artery trauma followed dTRA and fTRA

    Time frame: 90 days post-cardiac catheterization

    Number of participants with limited access site intimal tears, dissections, thrombosis, occlusions and pseudoaneurysms of the radial artery as assessed using ultrahigh resolution 55 MHz ultrasound at the site of puncture at 90 days post cardiac catheterization

  2. Functional assessment of the ipsilateral upper extremity following dTRA and fTRA

    Time frame: 90 days post-cardiac catheterization

    Pain and motor strength of the ipsilateral upper extremity using the Borg (0-none to 10-maximal) and Disabilities of the Arm, Shoulders and Hand (DASH) (0-no disability to 100-most severe disability) scales 90 days post-cardiac catheterization.

  3. Number of cannulation attempts

    Time frame: 24 hours post-cardiac catheterization

    Number of cannulation attempts prior to achieving successful vascular access

  4. Radial artery access time

    Time frame: 24 hours post-cardiac catheterization

    Time (minutes) from initial attempt to successful access of the radial artery.

  5. Access site crossover

    Time frame: 24 hours post-cardiac catheterization

    Number of patients with failure of radial artery cannulation requiring crossover to alternative radial artery access or transfemoral access

  6. Total procedural time

    Time frame: 24 hours post-cardiac catheterization

    Total procedural time (minutes) from time of access to completion of the cardiac catheterization.

  7. Duration of hemostasis

    Time frame: 24 hours post-cardiac catheterization

    Total duration of hemostasis (minutes) following completion of cardiac catheterization

  8. Incidence of hematomas

    Time frame: 24 hours post-cardiac catheterization

    Number of patients with EASY Class III or greater hematomas

  9. Percutaneous Coronary Intervention Success

    Time frame: 24 hours post-cardiac catheterization

    Achievement of Thrombolysis in Myocardial Infarction (TIMI) 3 flow following percutaneous coronary intervention

  10. Coronary dissection

    Time frame: 24 hours post-cardiac catheterization

    Iatrogenic coronary dissection at the of cardiac catheterization

  11. Myocardial infarction requiring revascularization

    Time frame: 24 hours post-cardiac catheterization

    Periprocedural myocardial infarction requiring urgent revascularization within 24 hours post-cardiac catheterization.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

PRESERVE Radial: A PRospEctive Randomized Clinical Study Comparing Radial ArtERy Intimal Hyperplasia Following Distal Vs. ForEarm TransRadial Arterial Access for Coronary Angiography

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2021
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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