Radial Artery Puncture Hemostasis Study

Not Applicable

Completed

• Conditions: Radial Artery Hemostasis
• Interventions: Device: Radial artery hemostasis

• Registration Number: NCT04857385
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief Summary

RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization.

A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices.

Follow-up of the subject will take place 60 days after the index procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-23
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Coronary angiogram planned from a radial artery approach
• Use of 5, 6 or 7 French sheaths

Exclusion Criteria

• Radial artery diameter <1.8 mm as measured via ultrasound
• Established peripheral arterial disease
• Known autoimmune illness
• Hemodynamic instability
• Pregnant or nursing
• Condition following resuscitation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
StatSeal	Radial artery hemostasis	Potassium-ferrate based chemical hemostasis device.
Terumo TR Band	Radial artery hemostasis	Physical standard of care radial hemostasis device.
Axiostat	Radial artery hemostasis	Chitosan based biological hemostasis device.

Primary Outcome Measures

Name	Time	Method
Radial artery fistula formation	60 days (+/-10 days) post-procedure	Frequency of radial artery arteriovenous fistula formation after hemostasis
Radial artery bleeding	60 days (+/-10 days) post-procedure	Bleeding from the radial artery puncture, classified via the EASY method
Radial artery occlusion	60 days (+/-10 days) post-procedure	Frequency of radial artery occlusion after hemostasis
Radial artery (pseudo)aneurysm formation	60 days (+/-10 days) post-procedure	Frequency of radial artery (pseudo)aneurysm formation after hemostasis

Secondary Outcome Measures

Name	Time	Method
Overall compression time	Up to 24 hours post-procedure	Overall time (in minutes) of device use as a hemostatis tool
Initial compression time of hemostatsis device	Up to 30 minutes post-procedure	Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis
Number of compression devices needed	Up to 24 hours post-procedure	Overall number of compression devices needed for hemostatis

Trial Locations

Locations (3)

University of Szeged, Department of Invasive Cardiology; 🇭🇺 Szeged, Csongád-Csanád, Hungary

Department of Cardiology and Cardiac Surgery; 🇭🇺 Debrecen, Hajdú-Bihar, Hungary

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary