Comparing TR Band to Statseal in Conjunction With TR Band
Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)
1 other identifier
interventional
184
1 country
1
Brief 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 Hemostasis (TTH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 13, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
March 12, 2018
CompletedApril 21, 2021
March 1, 2021
7 months
January 13, 2017
November 17, 2017
March 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
within 30 min of discharge or after 24 hours
Secondary Outcomes (1)
Percent of Patients With Radial Artery Occlusion(RAO)
within 30 min of discharge or after 24 hours
Study Arms (2)
TR Band Only
ACTIVE COMPARATORTR 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
EXPERIMENTALStatSeal: 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient undergoing diagnostic angiography or PCI via the radial artery
- Patients with a Barbeau test prior to the procedure showing pattern A,B,or
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veteran Affairs Long Beach
Long Beach, California, 90822, United States
Related Publications (1)
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.
PMID: 29769165RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Arnold Seto
- Organization
- VALBHS
Study Officials
- PRINCIPAL INVESTIGATOR
Arnold H Seto, M.D.
VA Long Beach Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Cardiology
Study Record Dates
First Submitted
January 13, 2017
First Posted
January 23, 2017
Study Start
January 1, 2017
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
April 21, 2021
Results First Posted
March 12, 2018
Record last verified: 2021-03