Comparing TR Band to Statseal in Conjunction With TR Band

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

The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs first, and the Time to Hemostasis (TTH).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Atherosclerosis; Angina Pectoris; Arterial Occlusion; Hematoma; Anticoagulant-Induced Bleeding
• Intervention / Treatment: Device: TR Band; Device: StatSeal

Detailed Description

This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at up to four experienced 'Radial First' centers (UCSD, UCLA. Arkansas Heart Hospital and LBVA). A maximum of 180 patients having undergone successful radial catheterization will be enrolled in the study, 60 in each arm. 60 patients will be enrolled at the LBVA. Enrollment will continue at each site on discretion of the investigators until each center enrolls a minimum of 30 patients, or a maximum of 180 patients are enrolled. Clinicians will perform the catheterization in accordance with local standard practice, with a minimum of 5,000 units of unfractionated heparin for anticoagulation. At the start of the TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam will be performed for all patients and recorded on the CRF. Ulnar compression will be applied to confirm that the radial artery is patent. Patients with a type D pattern exam will be excluded from the study. At the conclusion of a successful transradial procedure, the patient will be randomized to either SSA or TRB, each device applied per protocol & IFU. It is hypothesized that if radial artery compression time can be shortened to 40 minutes or less, the following could result: improved catheterization lab efficiency, greater patient satisfaction and lower complication rates, including RAO, may be improved.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Veteran Affairs Long Beach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
• Use of an anticoagulant other than unfractionated heparin or bivalirudin.
• Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein inhibitors are acceptable.
• 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.
• Mental incompetence or inability to follow the instructions to complete the study.
• History or presence of Radial Artery Occlusion.
• Barbeau test showing Pattern D.
• Patients undergoing catheterization from the femoral or ulnar artery approach.
• Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TR Band Only; TR Band: Patients randomly assigned to the control group 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 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.	Device: TR Band; Patients randomly assigned to the control group 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 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.; Other Names: Hemostasis device
Experimental: Statseal with TR Band; StatSeal: Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) 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 SSA disc with the center of the balloon (the green dot) over the center of the SSA 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 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.	Device: StatSeal; Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) 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 SSA disc with the center of the balloon (the green dot) over the center of the SSA 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 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.; Other Names: potassium ferrate disc with topical hydrophilic polymer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 min of discharge or after 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients With Radial Artery Occlusion(RAO)	Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.	within 30 min of discharge or after 24 hours

Collaborators and Investigators

• Sponsor: VA Long Beach Healthcare System
• Investigators: Principal Investigator: Arnold H Seto, M.D., VA Long Beach Hospital

Publications and helpful links

General Publications

• Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.

Helpful Links

• HTML link to document

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; TR band; radial artery occlusion; radial artery; Statseal; transradial catheterization; time to hemostasis; hemostasis band; potassium ferrate
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Hemorrhage; Coronary Disease; Chest Pain; Coronary Artery Disease; Cardiovascular Diseases; Atherosclerosis; Angina Pectoris; Hematoma; Coagulants; Hemostatics
• Other Study ID Numbers: MIRB 1427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes