Clinical trial NCT06991010: Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
Official title: One-arm, Prospective, Clinical Use Study of the Suction-Actuated Patent Hemostasis (SAPH) Device After a Transradial Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemostasis of Arterial Punctures
Keywords: Artery clamp
Transradial access
Radial artery patency
Radial artery hemostasis
Lead sponsor: Transradial Technologies, LLC
Sponsor class: INDUSTRY
Collaborators: name: RARAS CRO
First posted: 2025-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge
timeFrame: 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure.
measure: Safety Endpoints - 1) Percentage of subjects with radial artery patency 2) No major device-related access site-related complications prior to discharge
timeFrame: 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Transradial Technologies, LLC
name: Regulatory and Clinical Lead, PhD
role: STUDY_DIRECTOR
References: