Radial Artery Puncture Hemostasis Study (RAPHE)

Semmelweis University

Status: Completed

Conditions: Radial Artery Hemostasis

Treatments: Device: Radial artery hemostasis

Study type: Interventional

Funder types: Other

Identifiers

NCT04857385

RAPHE-001

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Terumo TR Band

Active Comparator group

Description:

Physical standard of care radial hemostasis device.

Treatment:

Device: Radial artery hemostasis

StatSeal

Experimental group

Description:

Potassium-ferrate based chemical hemostasis device.

Treatment:

Device: Radial artery hemostasis

Axiostat

Experimental group

Description:

Chitosan based biological hemostasis device.

Treatment:

Device: Radial artery hemostasis