Viewing Study NCT03993834



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Last Modification Date: 2024-10-26 @ 1:12 PM
Study NCT ID: NCT03993834
Status: COMPLETED
Last Update Posted: 2021-07-27
First Post: 2019-06-18

Brief Title: Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization
Sponsor: Insel Gruppe AG University Hospital Bern
Organization: Insel Gruppe AG University Hospital Bern

Study Overview

Official Title: Palmar Arch Insufficiency as a Risk Factor for Radial Artery Occlusion After Transradial Catheterization - a Single-Centre Observational Study
Status: COMPLETED
Status Verified Date: 2021-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PAIRAO
Brief Summary: Transradial access TRA is commonly used in different medical fields due to the superficial position of the radial artery and related advantages Despite its popularity the incidence and importance of related complications in particular radial artery occlusion RAO remains unclear Further the only known independent predictors of the radial artery occlusion are the periprocedural anticoagulation as well as the catheter size The effect of a variable arterial anatomy has so far not been evaluated

In this context most institutions prefer to evaluate the collateral circulation of the hand ie the arterial palmar arch and forearm circulation before TRA The most commonly employed tests are the modified Allen test MAT or the combination of pulse oximetry and plethysmography according to BarbeauIn addition there are more precise but still semi-quantitative non-invasive methods for palmar arterial collateral function testing

Despite the wealth of these variably accurate and practical tests invasive and direct hemodynamic measurement of the arterial forearm circulation and its components is lacking Thus the human physiologic circulatory reference at this site has been unknown so far Further the need of pre-procedural testing itself can be questioned in light of the reported widely varying prevalence of RAO 1-38 or critical ischemia 0-009 after TRA

The present study investigated in a first step the invasively obtained pressure-derived hemodynamic function ie the physiology of the human arterial palmar arch and forearm collateral circulation and in a second step the clinical consequences of the variable palmar arterial anatomy
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None