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

NCT ID: NCT06991010

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-11-28

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.

Conditions

Hemostasis of Arterial Punctures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAPH Device

All patients who have the SAPH device used to achieve hemostasis

Group Type: EXPERIMENTAL

Suction-Activated Patent Hemostasis (SAPH) Device

Intervention Type: DEVICE

A compression device intended to achieve patient hemostasis of the radial artery

Interventions

Suction-Activated Patent Hemostasis (SAPH) Device

A compression device intended to achieve patient hemostasis of the radial artery

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RARAS CRO

UNKNOWN

Sponsor Role: collaborator

Transradial Technologies, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regulatory and Clinical Lead, PhD

Role: STUDY_DIRECTOR

Transradial Technologies, LLC

Central Contacts

Regulatory and Clinical Lead

Role: CONTACT

jvargo1@outlook.com

908-420-2707

Other Identifiers

TT012025

Identifier Type: -

Identifier Source: org_study_id