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Completed

NCT Number: NCT04857385

Radial Artery Puncture Hemostasis Study

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.

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Key information

Conditions

Radial Artery Hemostasis Arterial Occlusive Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Szeged, Department of Invasive Cardiology, Szeged, Csongád-Csanád, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radial artery hemostasis

Device

Each of the devices will be assessed for radial artery hemostasis.

Primary outcomes

  1. Radial artery occlusion

    Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)

    Frequency of radial artery occlusion after hemostasis

  2. Radial artery occlusion

    Time frame: 60 days (+/-10 days) post-procedure

    Frequency of radial artery occlusion after hemostasis

  3. Radial artery (pseudo)aneurysm formation

    Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)

    Frequency of radial artery (pseudo)aneurysm formation after hemostasis

  4. Radial artery (pseudo)aneurysm formation

    Time frame: 60 days (+/-10 days) post-procedure

    Frequency of radial artery (pseudo)aneurysm formation after hemostasis

  5. Radial artery fistula formation

    Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)

    Frequency of radial artery arteriovenous fistula formation after hemostasis

  6. Radial artery fistula formation

    Time frame: 60 days (+/-10 days) post-procedure

    Frequency of radial artery arteriovenous fistula formation after hemostasis

  7. Radial artery bleeding

    Time frame: 24 hours post-procedure or at hospital discharge (whichever comes first)

    Bleeding from the radial artery puncture, classified via the EASY method

  8. Radial artery bleeding

    Time frame: 60 days (+/-10 days) post-procedure

    Bleeding from the radial artery puncture, classified via the EASY method

Secondary outcomes

  1. Initial compression time of hemostatsis device

    Time frame: Up to 30 minutes post-procedure

    Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis

  2. Overall compression time

    Time frame: Up to 24 hours post-procedure

    Overall time (in minutes) of device use as a hemostatis tool

  3. Number of compression devices needed

    Time frame: Up to 24 hours post-procedure

    Overall number of compression devices needed for hemostatis

Other outcomes

  1. Need for bail-out device

    Time frame: Up to 24 hours post-procedure

    Percentage of patients requiring bail-out hemostasis devices

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Registry information

Official study title

Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods

Acronym: RAPHE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2021
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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