Hemostasis of Arterial Punctures
Conditions
Keywords
Artery clamp, Transradial access, Radial artery patency, Radial artery hemostasis
Brief summary
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.
Detailed description
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.
Interventions
DEVICESuction-Activated Patent Hemostasis (SAPH) Device
A compression device intended to achieve patient hemostasis of the radial artery
Sponsors
RARAS CRO
Transradial Technologies, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is 21 years or older. 2. Patient is scheduled to undergo a coronary or peripheral catheterization procedure requiring 5 or 6 Fr transradial sheath access (TRA) with planned same-day discharge 3. Patient has a Reverse Barbeau test result of Type A, B or C (patent radial artery) 4. Patient is able to understand informed consent language 5. Patient is willing and able to sign informed consent and adhere to the protocol requirements
Exclusion criteria
1. Patient had a prior ipsilateral TRA procedure 2. Patient has scleroderma, vasculitis, or Raynaud's syndrome (primary or secondary) 3. Patient has cellulitis overlying radial artery 4. Patient requires uninterrupted oral systemic anticoagulation 5. Patient has intolerance to standard anticoagulants used in TRA procedures 6. Patient has non-palpable radial pulse or Reverse Barbeau test Type D response 7. Patient is participating in another investigational study 8. Patient is a prisoner 9. Patient, in the principal investigator's opinion, would not be able to comply with protocol requirements including self-report of comfort and 30-day follow up 10. Patient is receiving glycoprotein IIb/IIIa inhibitors 11. Patients with allergy to medical adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge | 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure. | 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. |
| Safety Endpoints - 1) Percentage of subjects with radial artery patency 2) No major device-related access site-related complications prior to discharge | 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure | Patency is defined as prominent digital arterial waveform signal by digital plethysmography with ulnar artery occlusion. |
Contacts
Primary ContactRegulatory and Clinical Lead
Outcome results
None listed