Distal Transradial Access for Percutaneous Coronary Intervention

Inova Health Care Services

Status: Completed

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

Treatments: Procedure: dTRA; Procedure: fTRA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04801901

U20-04-4021

Details and patient eligibility

About

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).

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Distal transradial access (dTRA)

Experimental group

Description:

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.

Treatment:

Procedure: dTRA

Forearm radial access (fTRA)

Active Comparator group

Description:

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.

Treatment:

Procedure: fTRA