Radial Artery Puncture Hemostasis Study

NCT04857385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-04-17

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04857385 on ClinicalTrials.gov