Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure

Transradial Technologies, LLC

Status: Not yet enrolling

Conditions: Hemostasis of Arterial Punctures

Treatments: Device: Suction-Activated Patent Hemostasis (SAPH) Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06991010

TT012025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

SAPH Device

Experimental group

Description:

All patients who have the SAPH device used to achieve hemostasis

Treatment:

Device: Suction-Activated Patent Hemostasis (SAPH) Device