Clinical trial NCT04046952: Comparing TR Band to Statseal in Conjunction With TR Band 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arterial Occlusion
Cardiovascular Diseases
Atherosclerosis
Hematoma
Anticoagulant-induced Bleeding
Coronary Artery Disease
Keywords: Radial Artery Occlusion
Time to Hemostasis
Statseal
TR Band
cardiac catheterization
transradial catheterization
percutaneous coronary intervention
Lead sponsor: VA Long Beach Healthcare System
Sponsor class: FED
First posted: 2019-08-06
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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 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.

Primary outcomes:
measure: Time to Hemostasis Using the Hemostasis Management System (HMS)
timeFrame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Secondary outcomes:
measure: Percent of Patients With Radial Artery Occlusion (RAO)
timeFrame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Veteran Affairs Long Beach
state: California
Study officials:
References:
citation: 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.