Clinical trial NCT04857385: Radial Artery Puncture Hemostasis Study
Official title: Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery Hemostasis
Keywords: Radial artery puncture
Radial artery occlusion
Radial artery bleeding
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Radial artery occlusion
timeFrame: 24 hours post-procedure or at hospital discharge (whichever comes first)
measure: Radial artery occlusion
timeFrame: 60 days (+/-10 days) post-procedure
measure: Radial artery (pseudo)aneurysm formation
timeFrame: 24 hours post-procedure or at hospital discharge (whichever comes first)
measure: Radial artery (pseudo)aneurysm formation
timeFrame: 60 days (+/-10 days) post-procedure
measure: Radial artery fistula formation
timeFrame: 24 hours post-procedure or at hospital discharge (whichever comes first)
measure: Radial artery fistula formation
timeFrame: 60 days (+/-10 days) post-procedure
measure: Radial artery bleeding
timeFrame: 24 hours post-procedure or at hospital discharge (whichever comes first)
measure: Radial artery bleeding
timeFrame: 60 days (+/-10 days) post-procedure
Secondary outcomes:
measure: Initial compression time of hemostatsis device
timeFrame: Up to 30 minutes post-procedure
measure: Overall compression time
timeFrame: Up to 24 hours post-procedure
measure: Number of compression devices needed
timeFrame: Up to 24 hours post-procedure
Other outcomes:
measure: Need for bail-out device
timeFrame: Up to 24 hours post-procedure
Locations:
city: Szeged
country: Hungary
facility: University of Szeged, Department of Invasive Cardiology
state: Csongád-Csanád
city: Debrecen
country: Hungary
facility: Department of Cardiology and Cardiac Surgery
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
Study officials:
affiliation: Semmelweis Univeristy Heart and Vascular Center
name: István F Édes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.