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

VA Long Beach Healthcare System

Status: Terminated

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Anticoagulant-induced Bleeding; Arterial Occlusion; Atherosclerosis; Hematoma

Treatments: Device: TR band only; Device: Statseal with TR Band

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04046952

MIRB 1843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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443 participants in 2 patient groups

TR band only

Active Comparator group

Description:

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.

Treatment:

Device: TR band only

Statseal with TR Band

Experimental group

Description:

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.

Treatment:

Device: Statseal with TR Band