Statseal II: Comparing TR Band to Statseal in Conjunction With TR Band II

Sponsor

VA Long Beach Healthcare System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT04046952

Collaborator

(none)

443

Enrollment

Location

Arms

14.2

Actual Duration (Months)

31.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Occlusion Cardiovascular Diseases Atherosclerosis Hematoma Anticoagulant-induced Bleeding Coronary Artery Disease	Device: Statseal with TR Band Device: TR band only	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

443 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2019

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 15, 2020

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

Time to Hemostasis using the Hemostasis Management System (HMS) [Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.]
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) [Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.]
Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.