Trial Outcomes & Findings for Comparing TR Band to Statseal in Conjunction With TR Band (NCT NCT03028025)
NCT ID: NCT03028025
Last Updated: 2021-04-21
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
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
within 30 min of discharge or after 24 hours
Results posted on
2021-04-21
Participant Flow
Participant milestones
| Measure |
TR Band Only
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 With TR Band
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.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
94
|
|
Overall Study
COMPLETED
|
87
|
93
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
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=87 Participants
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 With TR Band
n=93 Participants
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
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=87 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=180 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=87 Participants
|
38 Participants
n=93 Participants
|
73 Participants
n=180 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=87 Participants
|
55 Participants
n=93 Participants
|
107 Participants
n=180 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 9.8 • n=87 Participants
|
65.8 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
66.15 years
STANDARD_DEVIATION 10.8 • n=180 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=87 Participants
|
22 Participants
n=93 Participants
|
40 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=87 Participants
|
71 Participants
n=93 Participants
|
140 Participants
n=180 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
87 participants
n=87 Participants
|
93 participants
n=93 Participants
|
180 participants
n=180 Participants
|
|
Barbeau Class A
|
76 Participants
n=87 Participants
|
79 Participants
n=93 Participants
|
155 Participants
n=180 Participants
|
PRIMARY outcome
Timeframe: within 30 min of discharge or after 24 hoursTime 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=87 Participants
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 With TR Band
n=93 Participants
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.
|
|---|---|---|
|
Time to Hemostasis Using the Hemostasis Management System (HMS)
|
160 minutes
Standard Deviation 42.75
|
42.95 minutes
Standard Deviation 13.91
|
SECONDARY outcome
Timeframe: within 30 min of discharge or after 24 hoursRadial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.
Outcome measures
| Measure |
TR Band Only
n=87 Participants
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 With TR Band
n=93 Participants
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.
|
|---|---|---|
|
Percent of Patients With Radial Artery Occlusion(RAO)
|
0 Participants
|
2 Participants
|
Adverse Events
TR Band Only
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Statseal With TR Band
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TR Band Only
n=87 participants at risk
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 With TR Band
n=93 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Radial Artery Occlusion
|
0.00%
0/87 • 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.
All participants were monitored for radial artery occlusion as well as hematoma formation, and were reported if observed.
|
2.2%
2/93 • 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.
All participants were monitored for radial artery occlusion as well as hematoma formation, and were reported if observed.
|
|
Blood and lymphatic system disorders
Hematoma
|
10.3%
9/87 • 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.
All participants were monitored for radial artery occlusion as well as hematoma formation, and were reported if observed.
|
17.2%
16/93 • 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.
All participants were monitored for radial artery occlusion as well as hematoma formation, and were reported if observed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place