Distal Transradial Access for Percutaneous Coronary Intervention

Not Applicable

Completed

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

• Registration Number: NCT04801901
• Lead Sponsor: Inova Health Care Services

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).

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 Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-03-13
• Study First Posted: 2021-03-17
• Study Start: 2021-10-01
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal transradial access (dTRA)	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.
Forearm radial access (fTRA)	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States