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Comparing TR Band to Statseal in Conjunction With TR Band II (Statseal II)

Primary Purpose

Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Statseal with TR Band
TR band only
Sponsored by
VA Long Beach Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusion focused on measuring Radial Artery Occlusion, Time to Hemostasis, Statseal, TR Band, cardiac catheterization, transradial catheterization, percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria: any one of the following...

  • Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
  • Use of a hemostasis method or device besides the TR Band.
  • Patients undergoing catheterization from the femoral, brachial, ulnar, or distal radial (snuffbox) artery approach.
  • Use of an anticoagulant other than unfractionated heparin or bivalirudin.
  • Any use of glycoprotein inhibitors or cangrelor.
  • Use of sheathless guides.
  • Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
  • 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.
  • Inability of the patient to personally consent for the study. (no surrogate consent)
  • History or presence of Radial Artery Occlusion.
  • Barbeau test showing Pattern D.
  • Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.

Sites / Locations

  • Veteran Affairs Long Beach

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TR band only

Statseal with TR Band

Arm Description

Patients 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 60 minutes following the procedure for all patients (regardless of diagnostic or PCI procedure), after which full deflation attempts will commence.

Patients will have a Statseal Advance RAD (SS) 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 SS disc with the center of the balloon (the green dot) over the center of the SS 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 40 minutes (60 minutes after procedure), the TR band will be completely deflated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent of patients with radial artery occlusion (RAO)
Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.

Full Information

First Posted
August 2, 2019
Last Updated
March 29, 2021
Sponsor
VA Long Beach Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04046952
Brief Title
Comparing TR Band to Statseal in Conjunction With TR Band II
Acronym
Statseal II
Official Title
Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT) II
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Long Beach Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transradial procedures. It is believed that the use of both devices in combination compared to the hemostasis band (TR band) alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that you would need to wear the hemostasis band.
Detailed Description
This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at experienced 'Radial First' centers. A minimum of 800 patients having undergone successful radial catheterization will be enrolled in the study, 400 in each arm. Enrollment with continue at each site on discretion of the investigators until at least 800 patients are enrolled, with each center contributing a minimum of 50 patients. Clinicians will perform the catheterization in accordance with local standard practice, with no minimum amount of anticoagulation required. Unlike the pilot trial of this device, the present study will have an identical time to first deflation of 60 minutes between the two groups, and have a larger sample size to detect any excess risk of hematoma or radial artery occlusion. The study may also help demonstrate a relatively low rate of radial artery occlusion with a rapid deflation protocol, even at lower doses of unfractionated heparin than currently recommended.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-induced Bleeding, Coronary Artery Disease
Keywords
Radial Artery Occlusion, Time to Hemostasis, Statseal, TR Band, cardiac catheterization, transradial catheterization, percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR band only
Arm Type
Active Comparator
Arm Description
Patients 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 60 minutes following the procedure for all patients (regardless of diagnostic or PCI procedure), after which full deflation attempts will commence.
Arm Title
Statseal with TR Band
Arm Type
Experimental
Arm Description
Patients will have a Statseal Advance RAD (SS) 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 SS disc with the center of the balloon (the green dot) over the center of the SS 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 40 minutes (60 minutes after procedure), the TR band will be completely deflated.
Intervention Type
Device
Intervention Name(s)
Statseal with TR Band
Intervention Description
Patients will have a Statseal Advance RAD (SS) 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 SS disc with the center of the balloon (the green dot) over the center of the SS 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 40 minutes (60 minutes after procedure), the TR band will be completely deflated.
Intervention Type
Device
Intervention Name(s)
TR band only
Intervention Description
Patients 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 60 minutes following the procedure for all patients (regardless of diagnostic or PCI procedure), after which full deflation attempts will commence.
Primary Outcome Measure Information:
Title
Time to Hemostasis using the Hemostasis Management System (HMS)
Description
Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.
Time Frame
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Secondary Outcome Measure Information:
Title
Percent of patients with radial artery occlusion (RAO)
Description
Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.
Time Frame
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient undergoing diagnostic angiography or PCI via the radial artery Patients with a Barbeau test prior to the procedure showing pattern A,B,or C. Exclusion Criteria: any one of the following... Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed). Use of a hemostasis method or device besides the TR Band. Patients undergoing catheterization from the femoral, brachial, ulnar, or distal radial (snuffbox) artery approach. Use of an anticoagulant other than unfractionated heparin or bivalirudin. Any use of glycoprotein inhibitors or cangrelor. Use of sheathless guides. Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion. 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. Inability of the patient to personally consent for the study. (no surrogate consent) History or presence of Radial Artery Occlusion. Barbeau test showing Pattern D. Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.
Facility Information:
Facility Name
Veteran Affairs Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual participant data would be made available to other researchers upon request by email and coauthor credit.
IPD Sharing Time Frame
Starting May 1, 2021 and for 3 years thereafter.
IPD Sharing Access Criteria
Email and coauthor credit
Citations:
PubMed Identifier
35450681
Citation
Safirstein JG, Tehrani DM, Schussler JM, Reid N, Mukerjee K, Weber L, Liu H, Skenderian S, Simeon M, Yang T, Seto AH. Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):810-819. doi: 10.1016/j.jcin.2021.12.030.
Results Reference
derived

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Comparing TR Band to Statseal in Conjunction With TR Band II

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