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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Atherosclerosis; Arterial Occlusion; Hematoma; Anticoagulant-induced Bleeding
• Intervention / Treatment: Device: TR band only; Device: Statseal with TR 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.

• Study Type: Interventional
• Enrollment (Actual): 443
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Veteran Affairs Long Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TR band only; 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.	Device: TR band only; 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.
Experimental: Statseal with TR Band; 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.	Device: Statseal with TR Band; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients with radial artery occlusion (RAO)	Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.	Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.

Collaborators and Investigators

• Sponsor: VA Long Beach Healthcare System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: TR Band; percutaneous coronary intervention; Radial Artery Occlusion; cardiac catheterization; Time to Hemostasis; Statseal; transradial catheterization
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Hemorrhage; Coronary Disease; Coronary Artery Disease; Cardiovascular Diseases; Atherosclerosis; Hematoma
• Other Study ID Numbers: MIRB 1843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes