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Interim analysis at 50% of planned enrollment met prespecified critieria.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. |
| 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 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria: any one of the following...
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veteran Affairs Long Beach | Long Beach | California | 90822 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35450681 | Derived | 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. |
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Anonymized individual participant data would be made available to other researchers upon request by email and coauthor credit.
Starting May 1, 2021 and for 3 years thereafter.
Email and coauthor credit
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From October 2019 through December 2020, 443 patients were enrolled at 3 centers in the United States. Percutaneous coronary interventions (PCI) comprised 27% of procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | TR Band Only | 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. |
| FG001 | Statseal With TR Band | 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 pad with the center of the balloon (the green dot) over the center of the SS pad. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TR Band Only | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TR Band Only | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arnold Seto | Long Beach VA Healthcare System | 562-826-8000 | 12876 | arnold.seto@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2019 | Sep 15, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 10, 2019 | Sep 15, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D006406 | Hematoma |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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|
| 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. |
|
| BG001 | Statseal With TR Band | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Hypertension | Count of Participants | Participants |
|
| Hypercholesterolemia | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Barbeau's Class A | Barbeau's classification of adequacy of dual-circulation of the hand after compression of radial and ulnar artery and releasing ulnar artery. Class A: No damping of pulse tracing immediately after compression, Class B:Damping of pulse tracing, Class C:Loss of pulse tracing followed by recovery of pulse tracing within 2 minutes. Class D:Loss of pulse tracing without recovery within 2 minutes. A was considered normal and D was considered at highest risk for radial occlusion. | Count of Participants | Participants |
|
| Weak Pulse (<2+) | Operator's subjective evaluation of pulse, graded as 0 (absent), 1+ (weak), and 2+ (normal) | Count of Participants | Participants |
|
| OG001 | Statseal With TR Band | 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 pad with the center of the balloon (the green dot) over the center of the SS pad. 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. |
|
|
| Secondary | Percent of Patients With Radial Artery Occlusion (RAO) | Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry. | all patients examined | Posted | Count of Participants | Participants | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. |
|
|
|
| 0 |
| 220 |
| 0 |
| 220 |
| 18 |
| 220 |
| EG001 | Statseal With TR Band | 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 pad with the center of the balloon (the green dot) over the center of the SS pad. 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. | 0 | 223 | 0 | 223 | 10 | 223 |
| Bleeding requiring intervention | Blood and lymphatic system disorders | Systematic Assessment | any intervention beyond TR band reinflation |
|
| Radial artery occlusion | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |