Comparing TR Band to Statseal in Conjunction With TR Band II

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046952
• Other study ID #: MIRB 1843
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2021
• Source: VA Long Beach Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT03116438

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Arterial Occlusion
• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Hematoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Veteran Affairs Long Beach	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Long Beach Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.