NCT04801901

Distal Transradial Access for Percutaneous Coronary Intervention

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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)
PROCEDURE	fTRA	Left heart catheterization, coronary angiography and/or percutaneous coronary intervention using the left forearm radial artery.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-07-29
• Completion: 2022-07-29
• First posted: 2021-03-17
• Last updated: 2022-08-15

Locations

1 site across 1 country: United States