Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suction-Activated Patent Hemostasis (SAPH) Device.
- Who it may be relevant to
- Registry conditions: Hemostasis of Arterial Punctures. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
One-arm, Prospective, Clinical Use Study of the Suction-Activated Patent Hemostasis (SAPH) Device After a Transradial Procedure
Overview
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
- Device Suction-Activated Patent Hemostasis (SAPH) Device
A compression device intended to achieve patient hemostasis of the radial artery
Primary outcome measures
- Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge [Time frame: 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 [Time frame: 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure]
Eligibility criteria
Inclusion criteria
- Patient is 21 years or older.
- 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
- Patient has a Reverse Barbeau test result of Type A, B or C (patent radial artery)
- Patient is able to understand informed consent language
- Patient is willing and able to sign informed consent and adhere to the protocol requirements
Exclusion criteria
- Patient had a prior ipsilateral TRA procedure
- Patient has scleroderma, vasculitis, or Raynaud's syndrome (primary or secondary)
- Patient has cellulitis overlying radial artery
- Patient requires uninterrupted oral systemic anticoagulation
- Patient has intolerance to standard anticoagulants used in TRA procedures
- Patient has non-palpable radial pulse or Reverse Barbeau test Type D response
- Patient is participating in another investigational study
- Patient is a prisoner
- 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
- Patient is receiving glycoprotein IIb/IIIa inhibitors
- Patients with allergy to medical adhesives
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06991010 · TT012025