Arterial OcclusionNCT03028025

Comparing TR Band to Statseal in Conjunction With TR Band

A study testing StatSeal and TR Band in people with Arterial Occlusion and Angina Pectoris, run by VA Long Beach Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs first, and the Time to… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases
What is being tested?: StatSeal and TR Band
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2017to 1 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient undergoing diagnostic angiography or PCI via the radial artery
Patients with a Barbeau test prior to the procedure showing pattern A,B,or

Who cannot join

Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
Use of an anticoagulant other than unfractionated heparin or bivalirudin.
Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein inhibitors are acceptable.
Any active treatment with oral anticoagulants continued during course of procedure.
Presence of arteriovenous dialysis fistula in the ipsilateral arm.
Any physical deformity or trauma / injury of either wrist that would prevent proper placement or function of the hemostasis band.

Show all 12Show fewer

Raynaud's syndrome or known peripheral vascular disease of the forearm.
Mental incompetence or inability to follow the instructions to complete the study.
History or presence of Radial Artery Occlusion.
Barbeau test showing Pattern D.
Patients undergoing catheterization from the femoral or ulnar artery approach.
Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.

Trial locations and contacts

1 site in 1 country.

United States1 site

Veteran Affairs Long Beach
Long Beach, California, 90822

Other trials in United States

About this study

Official title: Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)

Read the detailed description

This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at up to four experienced 'Radial First' centers (UCSD, UCLA. Arkansas Heart Hospital and LBVA). A maximum of 180 patients having undergone successful radial catheterization will be enrolled in the study, 60 in each arm. 60 patients will be enrolled at the LBVA. Enrollment will continue at each site on discretion of the investigators until each center enrolls a minimum of 30 patients, or a maximum of 180 patients are enrolled. Clinicians will perform the catheterization in accordance with local standard practice, with a minimum of 5,000 units of unfractionated heparin for anticoagulation. At the start of the TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam will be performed for all patients and recorded on the CRF. Ulnar compression will be applied to confirm that the radial artery is patent. Patients with a type D pattern exam will be excluded from the study. At the conclusion of a successful transradial procedure, the patient will be randomized to either SSA or TRB, each device applied per protocol \& IFU. It is hypothesized that if radial artery compression time can be shortened to 40 minutes or less, the following could result: improved catheterization lab efficiency, greater patient satisfaction and lower complication rates, including RAO, may be improved.

Conditions: Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-Induced Bleeding
Being tested: StatSeal, TR Band
Keywords: radial artery occlusion, time to hemostasis, radial artery, transradial catheterization, TR band, Statseal, hemostasis band, potassium ferrate, percutaneous coronary intervention
Medical subject headings: Arterial Occlusive Diseases, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

StatSealDevice
Also called potassium ferrate disc with topical hydrophilic polymer
Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
TR BandDevice
Also called Hemostasis device
Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.

Study groups in NCT03028025
Study group	Role	What they receive
TR Band Only	Active comparator	TR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence. Receives: Device: TR Band
Statseal with TR Band	Experimental	StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed. Receives: Device: StatSeal

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Hemostasis Using the Hemostasis Management System (HMS)
Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.
Measured: within 30 min of discharge or after 24 hours

Secondary outcomes (1)

Percent of Patients With Radial Artery Occlusion(RAO)
Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.
Measured: within 30 min of discharge or after 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20171 Aug 2017

First posted23 Jan 2017 (estimated)
Study start1 Jan 2017
Primary completion1 Aug 2017
Study completion1 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arterial OcclusionStudies 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03028025
Sponsor's protocol ID: MIRB 1427
Status last verified: Mar 2021
First submitted: 13 Jan 2017
Last updated: 21 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.
PubMed 29769165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)
ClinicalTrials.gov ID: NCT03028025
Acronym / sponsor ID: MIRB 1427
Conditions: Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-Induced Bleeding
Keywords: radial artery occlusion, time to hemostasis, radial artery, transradial catheterization, TR band, Statseal, hemostasis band, potassium ferrate
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: VA Long Beach Healthcare SystemUS federal agency
Study start: 1 Jan 2017 (actual)
Primary completion: 1 Aug 2017 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 23 Jan 2017 (estimated)
Results: Posted 12 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TR Band Only	Active comparator	Device: TR BandTR Band: Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
Statseal with TR Band	Experimental	Device: StatSealStatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient undergoing diagnostic angiography or PCI via the radial artery
Patients with a Barbeau test prior to the procedure showing pattern A,B,or

Key exclusion criteria (12 listed)

Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
Use of an anticoagulant other than unfractionated heparin or bivalirudin.
Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein inhibitors are acceptable.
Any active treatment with oral anticoagulants continued during course of procedure.
Presence of arteriovenous dialysis fistula in the ipsilateral arm.

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
StatSealAlso: potassium ferrate disc with topical hydrophilic polymerPatients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.	Device	Statseal with TR Band
TR BandAlso: Hemostasis devicePatients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.	Device	TR Band Only

Primary outcome

Time to Hemostasis Using the Hemostasis Management System (HMS)
Time frame: within 30 min of discharge or after 24 hours
Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.

1 secondary outcome

Percent of Patients With Radial Artery Occlusion(RAO)
Time frame: within 30 min of discharge or after 24 hours

Results and safety

Results posted to the registry on 12 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TR Band Only	90	87
Statseal With TR Band	94	93

Primary outcome: Time to Hemostasis Using the Hemostasis Management System (HMS)

Time frame: within 30 min of discharge or after 24 hours. Mean (Standard Deviation). Unit: minutes

Measure	TR Band Only n = 87	Statseal With TR Band n = 93
Value	160 (42.75)	42.95 (13.91)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All participants in both groups were monitored post-cardiac catheterization until discharge. Discharge time varied per participant. Outpatient discharge time ranged from two to four hours (unless admitted as inpatient post-procedure). Inpatients were monitored until radial artery patency was observed post-procedure, and were observed for one to two days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TR Band Only	0 of 87 (0%)	9 of 87 (10.3%)	0 of 87
Statseal With TR Band	0 of 93 (0%)	18 of 93 (19.4%)	0 of 93

Limitations and caveats (from the sponsor): The study was not adequately powered for RAO/hematomas, and was open-label so could not be blinded. Our primary endpoint of time to TRB deflation was subject to differential treatment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29769165Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.
HTML link to documentLink provided by the sponsor.

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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. This study is not recruiting at the moment.

Arnold H Seto, M.D. principal investigator

VA Long Beach Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing StatSeal and TR Band in people with Arterial Occlusion and Angina Pectoris, run by VA Long Beach Healthcare System at 1 site in United States.

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 2 inclusion and 12 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: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Hemostasis Using the Hemostasis Management System (HMS) (time frame: within 30 min of discharge or after 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03028025, which also lists 1 linked publication.

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 21 Apr 2021.