Comparing TR Band to Statseal in Conjunction With TR Band II

NCT04046952 | Terminated Results FDA Device

• 1 other identifier: MIRB 1843
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent of Patients With Radial Artery Occlusion (RAO)

  Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.

Study Arms (2)

TR band only

ACTIVE COMPARATOR

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

Statseal with TR Band

EXPERIMENTAL

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

Interventions

Statseal with TR Band DEVICE

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.

Statseal with TR Band

TR band only DEVICE

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.

TR band only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Long Beach Healthcare System: lead

Study Sites (1)

Veteran Affairs Long Beach

Long Beach, California, 90822, United States

Location

Related Publications (1)

• 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.

  PMID: 35450681 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis; Hematoma; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Arteriosclerosis; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases

Limitations and Caveats

Early termination leading to smaller number of subjects analyzed. Inability to blind operator and clinical evaluator to presence of patch. Ultrasound evaluation not performed routinely.

Results Point of Contact

• Title: Dr. Arnold Seto
• Organization: Long Beach VA Healthcare System

arnold.seto@va.gov

562-826-8000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VA Long Beach Chief of Cardiology, Director of Interventional Cardiology Research

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 6, 2019
• Study Start: October 10, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Starting May 1, 2021 and for 3 years thereafter.
• Access Criteria: Email and coauthor credit

Locations

US (1)