Hemostasis of Arterial PuncturesNCT06991010
Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure
A study testing Suction-Activated Patent Hemostasis (SAPH) Device in people with Hemostasis of Arterial Punctures, run by Transradial Technologies, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemostasis of Arterial Punctures
- What is being tested?
- Suction-Activated Patent Hemostasis (SAPH) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: One-arm, Prospective, Clinical Use Study of the Suction-Activated Patent Hemostasis (SAPH) Device After a Transradial Procedure
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.
Read the 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
- Being tested
- Suction-Activated Patent Hemostasis (SAPH) Device
- Keywords
- Artery clamp, Transradial access, Radial artery patency, Radial artery hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction-Activated Patent Hemostasis (SAPH) DeviceDevice
A compression device intended to achieve patient hemostasis of the radial artery
| Study group | Role | What they receive |
|---|---|---|
| SAPH Device | Experimental | All patients who have the SAPH device used to achieve hemostasis Receives: Device: Suction-Activated Patent Hemostasis (SAPH) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint - Percent of subjects with radial artery hemostasis with patency at time of discharge
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.
Measured: 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
Patency is defined as prominent digital arterial waveform signal by digital plethysmography with ulnar artery occlusion.
Measured: 60 minutes prior to same-day discharge or within 24 hours post-TRA procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion28 Oct 2025 (estimated)
- Study completion28 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostasis of Arterial PuncturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transradial Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RARAS CRO
- Responsible party
- Sponsor
- Investigators
- Regulatory and Clinical Lead, PhD, Study director, Transradial Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991010
- Sponsor's protocol ID
- TT012025
- Status last verified
- Jul 2025
- First submitted
- 25 Apr 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Prospective, Clinical Use Study of the Suction-Activated Patent Hemostasis (SAPH) Device After a Transradial Procedure
- ClinicalTrials.gov ID
- NCT06991010
- Acronym / sponsor ID
- TT012025
- Conditions
- Hemostasis of Arterial Punctures
- Keywords
- Artery clamp, Transradial access, Radial artery patency, Radial artery hemostasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Transradial Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- RARAS CRO
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 28 Oct 2025 (estimated)
- Study completion
- 28 Nov 2025 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, nonrandomized, single-cohort, interventional clinical study
| Arm | Type | Receives |
|---|---|---|
| SAPH Device | Experimental | Device: Suction-Activated Patent Hemostasis (SAPH) DeviceAll patients who have the SAPH device used to achieve hemostasis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction-Activated Patent Hemostasis (SAPH) DeviceA compression device intended to achieve patient hemostasis of the radial artery | Device | SAPH Device |
Primary outcome
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.
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Hemostasis of Arterial Punctures
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Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
Femoral Artery Puncture, Vascular Closure Device
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Regulatory and Clinical Lead, PhD study director
Transradial Technologies, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Suction-Activated Patent Hemostasis (SAPH) Device in people with Hemostasis of Arterial Punctures, run by Transradial Technologies, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regulatory and Clinical Lead (908-420-2707, jvargo1@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.