Trial Outcomes & Findings for Comparing TR Band to Statseal in Conjunction With TR Band II (NCT NCT04046952)
NCT ID: NCT04046952
Last Updated: 2024-11-19
Results Overview
Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
443 participants
Primary outcome timeframe
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Results posted on
2024-11-19
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
220
|
223
|
|
Overall Study
COMPLETED
|
220
|
223
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TR Band Only
n=220 Participants
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
n=223 Participants
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.
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 11 • n=220 Participants
|
68 years
STANDARD_DEVIATION 10 • n=223 Participants
|
67.7 years
STANDARD_DEVIATION 10.2 • n=443 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=220 Participants
|
42 Participants
n=223 Participants
|
109 Participants
n=443 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=220 Participants
|
181 Participants
n=223 Participants
|
334 Participants
n=443 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
220 participants
n=220 Participants
|
223 participants
n=223 Participants
|
443 participants
n=443 Participants
|
|
Weight
|
199 lbs
STANDARD_DEVIATION 52 • n=220 Participants
|
203 lbs
STANDARD_DEVIATION 46 • n=223 Participants
|
200 lbs
STANDARD_DEVIATION 49 • n=443 Participants
|
|
Hypertension
|
167 Participants
n=220 Participants
|
176 Participants
n=223 Participants
|
343 Participants
n=443 Participants
|
|
Hypercholesterolemia
|
163 Participants
n=220 Participants
|
176 Participants
n=223 Participants
|
339 Participants
n=443 Participants
|
|
Diabetes Mellitus
|
69 Participants
n=220 Participants
|
86 Participants
n=223 Participants
|
155 Participants
n=443 Participants
|
|
Tobacco use
|
17 Participants
n=220 Participants
|
14 Participants
n=223 Participants
|
31 Participants
n=443 Participants
|
|
Barbeau's Class A
|
79 Participants
n=220 Participants
|
76 Participants
n=223 Participants
|
155 Participants
n=443 Participants
|
|
Weak Pulse (<2+)
|
76 Participants
n=220 Participants
|
92 Participants
n=223 Participants
|
168 Participants
n=443 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
TR Band Only
n=220 Participants
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
n=223 Participants
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.
|
|---|---|---|
|
Time to Hemostasis Using the Hemostasis Management System (HMS)
|
113 minutes
Standard Deviation 56
|
66 minutes
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.Population: all patients examined
Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.
Outcome measures
| Measure |
TR Band Only
n=220 Participants
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
n=223 Participants
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.
|
|---|---|---|
|
Percent of Patients With Radial Artery Occlusion (RAO)
|
2 Participants
|
1 Participants
|
Adverse Events
TR Band Only
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Statseal With TR Band
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TR Band Only
n=220 participants at risk
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
n=223 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Any hematoma
|
6.8%
15/220 • Number of events 15 • 1 day
|
4.0%
9/223 • Number of events 9 • 1 day
|
|
Blood and lymphatic system disorders
Bleeding requiring intervention
|
0.91%
2/220 • Number of events 2 • 1 day
|
0.00%
0/223 • 1 day
|
|
Blood and lymphatic system disorders
Radial artery occlusion
|
0.91%
2/220 • Number of events 2 • 1 day
|
0.45%
1/223 • Number of events 1 • 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place