NCT03558243

Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention

Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,425 (estimated)
• Sponsor: National Heart Institute, Mexico · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc.

Detailed description

The main complication of the transradial access is the occlusion of the radial artery, which although clinically silent in most cases, has been associated with critical hand ischemia, more importantly it limits the radial approach for future coronary interventions, and limits the use of this conduit for coronary revascularization surgery and arteriovenous fistulas. Factors that prevent occlusion of the radial artery have been identified, including the use of several hemostatic techniques at the conclusion of cardiac catheterization. The patent hemostasis defined as a technique that allows permeability of the radial artery and at the same time ensures the absence of bleeding was the first hemostatic method that showed a decrease in the incidence of radial artery occlusion, it is currently the quality standard for hemostasis in transradial access worldwide. Recently, the patent hemostasis plus ulnar compression was described, which proved in a randomized clinical trial to be superior to conventional patent haemostasis, decreasing the incidence of radial artery occlusion to 0.8% at 30 days. These hemostatic methods are a subject of current research worldwide. And more clinical trials are expected to confirm the superiority of patent hemostasis plus ulnar compression. The hemostatic discs used at the beginning as an attempt to reduce the times for the hemostasis of the radial access and therefore the recovery times in units of high volume have attracted attention for their effectiveness and their low incidence of radial artery occlusion, there are few reports who place it as a potential strategy to reduce the incidence of radial artery occlusion. Its effectiveness should be validated in dedicated trials with an adequate sample size.

Conditions

• Occlusion of Artery
• Radial Artery Injury
• Complication

Interventions

Type	Name	Description
PROCEDURE	Patent Hemostasis arm	Patent hemostasis with TR BAND
PROCEDURE	ULTRA arm	Patent hemostasis protocol plus ipsilateral ulnar compression
DEVICE	Hemostatic disc arm	StatSeal disc plus TR Band

Timeline

• Start date: 2018-05-01
• Primary completion: 2020-08-30
• Completion: 2020-10-30
• First posted: 2018-06-15
• Last updated: 2020-03-19

Locations

1 site across 1 country: Mexico