Distal Transradial Access for Percutaneous Coronary Intervention

August 12, 2022 updated by: Dr. Wayne B. Batchelor M.D., Inova Health Care Services

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Patients who are not willing to undergo the necessary follow-up ultrasound examinations.
  3. ST elevation myocardial infarction or other emergent PCI
  4. Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Distal transradial access (dTRA)
Subjects randomized to the experimental arm will undergo left heart catheterization using distal transradial access (dTRA) to facilitate coronary angiography and/or percutaneous coronary intervention.
Procedure: dTRA
Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)
Active Comparator: Forearm radial access (fTRA)
Cardiac catheterization to facilitate coronary angiography and/or percutaneous coronary intervention using the standard forearm radial artery which is the current standard of care in interventional cardiology.
Procedure: fTRA
Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days post-cardiac catheterization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days post-cardiac catheterization
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.
90 days post-cardiac catheterization
Number of cannulation attempts
Time Frame: 24 hours post-cardiac catheterization
Number of cannulation attempts prior to achieving successful vascular access
24 hours post-cardiac catheterization
Radial artery access time
Time Frame: 24 hours post-cardiac catheterization
Time (minutes) from initial attempt to successful access of the radial artery.
24 hours post-cardiac catheterization
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
24 hours post-cardiac catheterization
Total procedural time
Time Frame: 24 hours post-cardiac catheterization
Total procedural time (minutes) from time of access to completion of the cardiac catheterization.
24 hours post-cardiac catheterization
Duration of hemostasis
Time Frame: 24 hours post-cardiac catheterization
Total duration of hemostasis (minutes) following completion of cardiac catheterization
24 hours post-cardiac catheterization
Incidence of hematomas
Time Frame: 24 hours post-cardiac catheterization
Number of patients with EASY Class III or greater hematomas
24 hours post-cardiac catheterization
Percutaneous Coronary Intervention Success
Time Frame: 24 hours post-cardiac catheterization
Achievement of Thrombolysis in Myocardial Infarction (TIMI) 3 flow following percutaneous coronary intervention
24 hours post-cardiac catheterization
Coronary dissection
Time Frame: 24 hours post-cardiac catheterization
Iatrogenic coronary dissection at the of cardiac catheterization
24 hours post-cardiac catheterization
Myocardial infarction requiring revascularization
Time Frame: 24 hours post-cardiac catheterization
Periprocedural myocardial infarction requiring urgent revascularization within 24 hours post-cardiac catheterization.
24 hours post-cardiac catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Collaborators

Boston Scientific Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

July 29, 2022

Study Completion (Actual)

July 29, 2022

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

March 13, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • U20-04-4021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual patient data including demographics, cardiac history indications for cardiac catheterization and all follow up data related to primary outcome, secondary ultrasound endpoints, interventional endpoints and secondary functional outcomes will be shared.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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