NCT04046952

Comparing TR Band to Statseal in Conjunction With TR Band II

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 443 (actual)
• Sponsor: VA Long Beach Healthcare System · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Patients having undergone successful radial catheterization will be enrolled in the study. Enrollment with continue at each site with an initial goal of 800 patients enrolled, with each center contributing a minimum of 50 patients. Study will be have a single interim analysis after 400 patients are enrolled for efficacy and safety and continuation of the study. 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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-10-10
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2019-08-06
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study