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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terumo TR Band | Active Comparator | Physical standard of care radial hemostasis device. |
|
| StatSeal | Experimental | Potassium-ferrate based chemical hemostasis device. |
|
| Axiostat | Experimental | Chitosan based biological hemostasis device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radial artery hemostasis | Device | Each of the devices will be assessed for radial artery hemostasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Initial compression time of hemostatsis device | Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis | Up to 30 minutes post-procedure |
| Overall compression time |
| Measure | Description | Time Frame |
|---|---|---|
| Need for bail-out device | Percentage of patients requiring bail-out hemostasis devices | Up to 24 hours post-procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| István F Édes, MD PhD | Semmelweis Univeristy Heart and Vascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged, Department of Invasive Cardiology | Szeged | Csongád-Csanád | 6725 | Hungary | ||
| Department of Cardiology and Cardiac Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35694680 | Background | 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. | |
| 42189195 |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Radial artery bleeding | Bleeding from the radial artery puncture, classified via the EASY method | 60 days (+/-10 days) post-procedure |
Overall time (in minutes) of device use as a hemostatis tool
| Up to 24 hours post-procedure |
| Number of compression devices needed | Overall number of compression devices needed for hemostatis | Up to 24 hours post-procedure |
| Debrecen |
| Hajdú-Bihar |
| 4032 |
| Hungary |
| Semmelweis University Heart and Vascular Center | Budapest | 1122 | Hungary |
| Kulyassa PM, Nemeth BT, Ruzsa Z, Szuk T, Ehrenberger R, Balazs B, Kakonyi KM, Becker D, Merkely BP, Edes IF. Simplified radial artery haemostasis: using non-compressive dressings-the Radial Artery Puncture Haemostasis Evaluation trial: results of the RAPHE trial. Clin Res Cardiol. 2026 May 26. doi: 10.1007/s00392-026-02942-2. Online ahead of print. |