Radial Artery Puncture Hemostasis Study
NCT04857385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2024-04-17
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.
Conditions
- Radial Artery Hemostasis
Interventions
- DEVICE
-
Radial artery hemostasis
Each of the devices will be assessed for radial artery hemostasis.
Sponsors & Collaborators
-
Semmelweis University Heart and Vascular Center
lead OTHER
Principal Investigators
-
István F Édes, MD PhD · Semmelweis Univeristy Heart and Vascular Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-14
- Primary Completion
- 2024-01-01
- Completion
- 2024-01-01
Countries
- Hungary
Study Locations
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