Comparing TR Band to Statseal in Conjunction With TR Band

• Sponsor: VA Long Beach Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03028025
• Collaborator: (none)
• Enrollment: 184
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 26.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Arterial Occlusion; Angina Pectoris; Cardiovascular Diseases; Atherosclerosis; Hematoma; Anticoagulant-Induced Bleeding; Coronary Artery Disease	Device: StatSeal; Device: TR Band	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 184 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time to Hemostasis Using the Hemostasis Management System (HMS) [within 30 min of discharge or after 24 hours]

   Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.

Secondary Outcome Measures

1. Percent of Patients With Radial Artery Occlusion(RAO) [within 30 min of discharge or after 24 hours]

   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: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veteran Affairs Long Beach	Long Beach	California	United States	90822

Sponsors and Collaborators

• VA Long Beach Healthcare System

Investigators

• Principal Investigator: Arnold H Seto, M.D., VA Long Beach Hospital

Study Documents (Full-Text)

• Study Protocol - Sep 12, 2016
• Statistical Analysis Plan - Nov 1, 2017

More Information

Additional Information:

• HTML link to document

Publications

None provided.

• Responsible Party: Arnold Seto, Chief of Cardiology, VA Long Beach Healthcare System
• ClinicalTrials.gov Identifier: NCT03028025
• Other Study ID Numbers: MIRB 1427
• First Posted: Jan 23, 2017
• Last Update Posted: Apr 21, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Arnold Seto, Chief of Cardiology, VA Long Beach Healthcare System: radial artery occlusion; time to hemostasis; radial artery; transradial catheterization; TR band; Statseal; hemostasis band; potassium ferrate; percutaneous coronary intervention
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Atherosclerosis; Angina Pectoris; Hematoma; Hemostatics

Study Results

Participant Flow

Arm/Group Title	TR Band Only	Statseal With TR Band
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	90	94
COMPLETED	87	93
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	TR Band Only	Statseal With TR Band	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	87	93	180
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	35 40.2%	38 40.9%	73 40.6%
>=65 years	52 59.8%	55 59.1%	107 59.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.5 (9.8)	65.8 (11.8)	66.15 (10.8)
Sex: Female, Male (Count of Participants)
Female	18 20.7%	22 23.7%	40 22.2%
Male	69 79.3%	71 76.3%	140 77.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	87 100%	93 100%	180 100%
Barbeau Class A (Count of Participants)
Count of Participants [Participants]	76 87.4%	79 84.9%	155 86.1%

Outcome Measures

1. Primary Outcome

Title	Time to Hemostasis Using the Hemostasis Management System (HMS)
Description	Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.
Time Frame	within 30 min of discharge or after 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TR Band Only	Statseal With TR Band
Arm/Group Description	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.	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.
Measure Participants	87	93
Mean (Standard Deviation) [minutes]	160 (42.75)	42.95 (13.91)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TR Band Only	Statseal With TR Band
Arm/Group Description	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.	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.
Measure Participants	87	93
Count of Participants [Participants]	0 0%	2 2.2%

Adverse Events

Time Frame	All participants in both groups were monitored post-cardiac catheterization until discharge. Discharge time varied per participant. Outpatient discharge time ranged from two to four hours (unless admitted as inpatient post-procedure). Inpatients were monitored until radial artery patency was observed post-procedure, and were observed for one to two days.
Adverse Event Reporting Description	All participants were monitored for radial artery occlusion as well as hematoma formation, and were reported if observed.
Arm/Group Title	TR Band Only		Statseal With TR Band
Arm/Group Description	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.		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.
All Cause Mortality
	TR Band Only		Statseal With TR Band
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/93 (0%)
Serious Adverse Events
	TR Band Only		Statseal With TR Band
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/93 (0%)
Other (Not Including Serious) Adverse Events
	TR Band Only		Statseal With TR Band
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/87 (10.3%)		18/93 (19.4%)
Blood and lymphatic system disorders
Radial Artery Occlusion	0/87 (0%)		2/93 (2.2%)
Hematoma	9/87 (10.3%)		16/93 (17.2%)

Limitations/Caveats

The study was not adequately powered for RAO/hematomas, and was open-label so could not be blinded. Our primary endpoint of time to TRB deflation was subject to differential treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.