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| Name | Class |
|---|---|
| RARAS CRO | UNKNOWN |
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This is a prospective, multicenter study intended to provide supportive clinical information on the use of the SAPH device to achieve radial artery patent hemostasis after a transradial procedure.
This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study intended to provide supportive clinical information to the nonclinical characterization and performance data required for demonstration of substantial equivalence to marketed devices. The study will assess clinical use elements such as ease of use, patient comfort, as well as safety and effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAPH Device | Experimental | All patients who have the SAPH device used to achieve hemostasis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suction-Activated Patent Hemostasis (SAPH) Device | Device | A compression device intended to achieve patient hemostasis of the radial artery |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge | Radial artery hemostasis with patency is defined as hemostasis over the arterial puncture site with palpable distal radial pulse or prominent digital arterial waveform signal by digital plethysmography with ulnar occlusion. | 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure. |
| Safety Endpoints - 1) Percentage of subjects with radial artery patency 2) No major device-related access site-related complications prior to discharge | Patency is defined as prominent digital arterial waveform signal by digital plethysmography with ulnar artery occlusion. | 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regulatory and Clinical Lead | Contact | 908-420-2707 | jvargo1@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Regulatory and Clinical Lead, PhD | Transradial Technologies, LLC | Study Director |
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This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study
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