NCT04857385

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

2.7 years

First QC Date

April 20, 2021

Last Update Submit

April 16, 2024

Conditions

Radial Artery Hemostasis

Keywords

Radial artery punctureRadial artery occlusionRadial artery bleeding

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (3)

  • Initial compression time of hemostatsis device

    Up to 30 minutes post-procedure

  • Overall compression time

    Up to 24 hours post-procedure

  • Number of compression devices needed

    Up to 24 hours post-procedure

Other Outcomes (1)

  • Need for bail-out device

    Up to 24 hours post-procedure

Study Arms (3)

Terumo TR Band

ACTIVE COMPARATOR

Physical standard of care radial hemostasis device.

Device: Radial artery hemostasis

StatSeal

EXPERIMENTAL

Potassium-ferrate based chemical hemostasis device.

Device: Radial artery hemostasis

Axiostat

EXPERIMENTAL

Chitosan based biological hemostasis device.

Device: Radial artery hemostasis

Interventions

Radial artery hemostasisDEVICE

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

AxiostatStatSealTerumo TR Band

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary angiogram planned from a radial artery approach
  • Use of 5, 6 or 7 French sheaths

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Szeged, Department of Invasive Cardiology

Szeged, Csongád-Csanád, 6725, Hungary

Location

Department of Cardiology and Cardiac Surgery

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (1)

  • 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.

    PMID: 35694680BACKGROUND

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • István F Édes, MD PhD

    Semmelweis Univeristy Heart and Vascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 23, 2021

Study Start

April 14, 2021

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

HU(3)