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Distal Transradial Access for Percutaneous Coronary Intervention

Sponsor
Inova Health Care Services (Other)
Overall Status
Completed
CT.gov ID
NCT04801901
Collaborator
Boston Scientific Corporation (Industry)
64
Enrollment
1
Location
2
Arms
9.9
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: dTRA
  • Procedure: fTRA
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized non-blinded study evaluating whether distal radial artery access (dTRA) from the anatomic snuffbox is associated with less trauma and adverse remodeling to the forearm radial artery compared to standardard forearm radial access (fTRA).Prospective randomized non-blinded study evaluating whether distal radial artery access (dTRA) from the anatomic snuffbox is associated with less trauma and adverse remodeling to the forearm radial artery compared to standardard forearm radial access (fTRA).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PRESERVE Radial: A PRospEctive Randomized Clinical Study Comparing Radial ArtERy Intimal Hyperplasia Following Distal Vs. ForEarm TransRadial Arterial Access for Coronary Angiography
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Jul 29, 2022
Actual Study Completion Date :
Jul 29, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Radial artery intimal medial thickness following dTRA and fTRA [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 Outcome Measures

  1. Radial artery trauma followed dTRA and fTRA [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 [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 [24 hours post-cardiac catheterization]

    Number of cannulation attempts prior to achieving successful vascular access

  4. Radial artery access time [24 hours post-cardiac catheterization]

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

  5. Access site crossover [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 [24 hours post-cardiac catheterization]

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

  7. Duration of hemostasis [24 hours post-cardiac catheterization]

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

  8. Incidence of hematomas [24 hours post-cardiac catheterization]

    Number of patients with EASY Class III or greater hematomas

  9. Percutaneous Coronary Intervention Success [24 hours post-cardiac catheterization]

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

  10. Coronary dissection [24 hours post-cardiac catheterization]

    Iatrogenic coronary dissection at the of cardiac catheterization

  11. Myocardial infarction requiring revascularization [24 hours post-cardiac catheterization]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inova Fairfax Hospital Falls Church Virginia United States 22042

Sponsors and Collaborators

  • Inova Health Care Services
  • Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Wayne B. Batchelor M.D., Director of Interventional Cardiology, Inova Heart and Vascular Institute, Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT04801901
Other Study ID Numbers:
  • U20-04-4021
First Posted:
Mar 17, 2021
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 15, 2022