Radial Artery Puncture Hemostasis Study (RAPHE)

Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods

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.

Study Overview

• Status: Completed
• Conditions: Radial Artery Hemostasis
• Intervention / Treatment: Device: Radial artery hemostasis

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University Heart and Vascular Center
  • Csongád-Csanád
    • Szeged, Csongád-Csanád, Hungary, 6725
      • University of Szeged, Department of Invasive Cardiology
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Department of Cardiology and Cardiac Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Terumo TR Band; Physical standard of care radial hemostasis device.	Device: Radial artery hemostasis; Each of the devices will be assessed for radial artery hemostasis.
Experimental: StatSeal; Potassium-ferrate based chemical hemostasis device.	Device: Radial artery hemostasis; Each of the devices will be assessed for radial artery hemostasis.
Experimental: Axiostat; Chitosan based biological hemostasis device.	Device: Radial artery hemostasis; Each of the devices will be assessed for radial artery hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery occlusion	Frequency of radial artery occlusion after hemostasis	24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery occlusion	Frequency of radial artery occlusion after hemostasis	60 days (+/-10 days) post-procedure
Radial artery (pseudo)aneurysm formation	Frequency of radial artery (pseudo)aneurysm formation after hemostasis	24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery (pseudo)aneurysm formation	Frequency of radial artery (pseudo)aneurysm formation after hemostasis	60 days (+/-10 days) post-procedure
Radial artery fistula formation	Frequency of radial artery arteriovenous fistula formation after hemostasis	24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery fistula formation	Frequency of radial artery arteriovenous fistula formation after hemostasis	60 days (+/-10 days) post-procedure
Radial artery bleeding	Bleeding from the radial artery puncture, classified via the EASY method	24 hours post-procedure or at hospital discharge (whichever comes first)
Radial artery bleeding	Bleeding from the radial artery puncture, classified via the EASY method	60 days (+/-10 days) post-procedure

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for bail-out device	Percentage of patients requiring bail-out hemostasis devices	Up to 24 hours post-procedure

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Investigators: Principal Investigator: István F Édes, MD PhD, Semmelweis Univeristy Heart and Vascular Center

Publications and helpful links

General Publications

• Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Radial artery occlusion; Radial artery puncture; Radial artery bleeding
• Additional Relevant MeSH Terms: Coagulants; Hemostatics
• Other Study ID Numbers: RAPHE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No