search
Back to results

Comparing TR Band to Statseal in Conjunction With TR Band

Primary Purpose

Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases

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

About this trial

This is an interventional health services research trial for Arterial Occlusion focused on measuring radial artery occlusion, time to hemostasis, radial artery, transradial catheterization, TR band, Statseal, hemostasis band, potassium ferrate, 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

Exclusion Criteria:

  • 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.

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

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.

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.

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
January 13, 2017
Last Updated
March 29, 2021
Sponsor
VA Long Beach Healthcare System
search

1. Study Identification

Unique Protocol Identification Number
NCT03028025
Brief Title
Comparing TR Band to Statseal in Conjunction With TR Band
Official Title
Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (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 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-Induced Bleeding, Coronary Artery Disease
Keywords
radial artery occlusion, time to hemostasis, radial artery, transradial catheterization, TR band, Statseal, hemostasis band, potassium ferrate, percutaneous coronary intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR Band Only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Statseal with TR Band
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
StatSeal
Other Intervention Name(s)
potassium ferrate disc with topical hydrophilic polymer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TR Band
Other Intervention Name(s)
Hemostasis device
Intervention Description
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.
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 min of discharge or after 24 hours
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 min of discharge or after 24 hours

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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold H Seto, M.D.
Organizational Affiliation
VA Long Beach Hospital
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
29769165
Citation
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.
Results Reference
result
Links:
URL
https://eurointervention.pcronline.com/article/radial-haemostasis-is-facilitated-with-a-potassium-ferrate-haemostatic-patch-the-statseal-with-tr-band-assessment-trial-stat
Description
HTML link to document

Learn more about this trial

Comparing TR Band to Statseal in Conjunction With TR Band

We'll reach out to this number within 24 hrs