Distal Transradial Access for Percutaneous Coronary Intervention

NCT04801901 | Completed

• 1 other identifier: U20-04-4021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Radial artery intimal medial thickness following dTRA and fTRA

  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 Outcomes (11)

• Radial artery trauma followed dTRA and fTRA

  90 days post-cardiac catheterization

• Functional assessment of the ipsilateral upper extremity following dTRA and fTRA

  90 days post-cardiac catheterization

• Number of cannulation attempts

  24 hours post-cardiac catheterization

• Radial artery access time

  24 hours post-cardiac catheterization

• Access site crossover

  24 hours post-cardiac catheterization

Study Arms (2)

Distal transradial access (dTRA)

EXPERIMENTAL

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

Forearm radial access (fTRA)

ACTIVE COMPARATOR

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

Interventions

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)

Distal transradial access (dTRA)

fTRA PROCEDURE

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

Forearm radial access (fTRA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (23)

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• Tehrani BN, Sherwood MW, Damluji AA, Epps KC, Bakhshi H, Cilia L, Dassanayake I, Eltebaney M, Gattani R, Howard E, Kepplinger D, Ofosu-Somuah A, Batchelor WB. A Randomized Comparison of Radial Artery Intimal Hyperplasia Following Distal Versus Proximal Transradial Access for Coronary Angiography: PRESERVE RADIAL. J Am Heart Assoc. 2024 Feb 20;13(4):e031504. doi: 10.1161/JAHA.123.031504. Epub 2024 Feb 14.

  PMID: 38353242 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Interventional Cardiology, Inova Heart and Vascular Institute

Model Details: 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).

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: March 17, 2021
• Study Start: October 1, 2021
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)