Distal Transradial Access for Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: dTRA
* Procedure: fTRA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal transradial access (dTRA)<br>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<br>* Subjects randomized to the experimental arm will undergo left heart catheterization, coronary angiography and/or percutaneous coronary intervention using distal transradial access (dTRA)<br>|
| Active Comparator: Forearm radial access (fTRA)<br>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<br>* Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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