Anticoagulant-induced Bleeding, Arterial Occlusion, Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Hematoma
Conditions
Keywords
Radial Artery Occlusion, Time to Hemostasis, Statseal, TR Band, cardiac catheterization, transradial catheterization, percutaneous coronary intervention
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.
Detailed 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.
Interventions
DEVICEStatseal 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.
DEVICETR 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.
Sponsors
VA Long Beach Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis Using the Hemostasis Management System (HMS) | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. | Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Radial Artery Occlusion (RAO) | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. | Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 220 |
| 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. | 223 |
| Total | 443 |
Baseline characteristics
| Characteristic | TR Band Only | Statseal With TR Band | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 11 | 68 years STANDARD_DEVIATION 10 | 67.7 years STANDARD_DEVIATION 10.2 |
| Barbeau's Class A | 79 Participants | 76 Participants | 155 Participants |
| Diabetes Mellitus | 69 Participants | 86 Participants | 155 Participants |
| Hypercholesterolemia | 163 Participants | 176 Participants | 339 Participants |
| Hypertension | 167 Participants | 176 Participants | 343 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 220 participants | 223 participants | 443 participants |
| Sex: Female, Male Female | 67 Participants | 42 Participants | 109 Participants |
| Sex: Female, Male Male | 153 Participants | 181 Participants | 334 Participants |
| Tobacco use | 17 Participants | 14 Participants | 31 Participants |
| Weak Pulse (<2+) | 76 Participants | 92 Participants | 168 Participants |
| Weight | 199 lbs STANDARD_DEVIATION 52 | 203 lbs STANDARD_DEVIATION 46 | 200 lbs STANDARD_DEVIATION 49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 220 | 0 / 223 |
| other Total, other adverse events | 18 / 220 | 10 / 223 |
| serious Total, serious adverse events | 0 / 220 | 0 / 223 |
Outcome results
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.
Time frame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TR Band Only | Time to Hemostasis Using the Hemostasis Management System (HMS) | 113 minutes | Standard Deviation 56 |
| Statseal With TR Band | Time to Hemostasis Using the Hemostasis Management System (HMS) | 66 minutes | Standard Deviation 14 |
Secondary
Percent of Patients With Radial Artery Occlusion (RAO)
Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.
Time frame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Population: all patients examined
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TR Band Only | Percent of Patients With Radial Artery Occlusion (RAO) | 2 Participants |
| Statseal With TR Band | Percent of Patients With Radial Artery Occlusion (RAO) | 1 Participants |