Trial Outcomes & Findings for Patent Hemostasis With Vasoband Versus TR Band (NCT NCT04002791)
NCT ID: NCT04002791
Last Updated: 2020-11-13
Results Overview
Patent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
0-15 minutes
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Group 1: TR Band Arm
Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using "Patent hemostasis protocol" to achieve full hemostasis.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
Group 2: Vaso-band Arm
Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
126
|
|
Overall Study
COMPLETED
|
127
|
126
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patent Hemostasis With Vasoband Versus TR Band
Baseline characteristics by cohort
| Measure |
Group 1: TR Band Arm
n=127 Participants
Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using "Patent hemostasis protocol" to achieve full hemostasis.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
Group 2: Vaso-band Arm
n=126 Participants
Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10 • n=5 Participants
|
59 years
STANDARD_DEVIATION 11 • n=7 Participants
|
58 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
INDIAN
|
127 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Hypertension
|
80 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Diabetes
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Previous PCI
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Previous CABG
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Height
|
165 Centimeter
n=5 Participants
|
165 Centimeter
n=7 Participants
|
165 Centimeter
n=5 Participants
|
|
Weight
|
72 Kilograms
n=5 Participants
|
71 Kilograms
n=7 Participants
|
71 Kilograms
n=5 Participants
|
|
Hemoglobin
|
13.5 Gram/Dl
n=5 Participants
|
13.2 Gram/Dl
n=7 Participants
|
13.3 Gram/Dl
n=5 Participants
|
|
Platelets
|
270 Cells x1000/ml
n=5 Participants
|
250.5 Cells x1000/ml
n=7 Participants
|
261 Cells x1000/ml
n=5 Participants
|
|
Serum Creatinine
|
0.91 mg/dl
n=5 Participants
|
0.91 mg/dl
n=7 Participants
|
0.91 mg/dl
n=5 Participants
|
|
Wrist Circumference
|
21 cm
n=5 Participants
|
20 cm
n=7 Participants
|
20 cm
n=5 Participants
|
|
Barbeau Test Pattern A
|
70 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Barbeau Test Pattern B
|
53 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Barbeau Test Pattern C
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-15 minutesPatent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression
Outcome measures
| Measure |
Group 1: TR Band Arm
n=127 Participants
Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using "Patent hemostasis protocol" to achieve full hemostasis.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
Group 2: Vaso-band Arm
n=126 Participants
Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
|---|---|---|
|
Number of Patients Who Achieved Patent Hemostasis
|
94 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: 0-60 minutesAbsence of Patency of radial artery at 1-hour after removal of hemostatic compression
Outcome measures
| Measure |
Group 1: TR Band Arm
n=127 Participants
Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using "Patent hemostasis protocol" to achieve full hemostasis.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
Group 2: Vaso-band Arm
n=126 Participants
Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
|---|---|---|
|
Number of Participants With Radial Artery Occlusion One Hour After Removal of Hemostatic Compression
|
13 Participants
|
2 Participants
|
Adverse Events
Group 1: TR Band Arm
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Vaso-band Arm
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: TR Band Arm
n=127 participants at risk
Patients will receive hemostatic compression using the current standard of care TR band (Terumo Corporation, Japan). The band will be applied according to the instructions for use, with optimal pressure applied using "Patent hemostasis protocol" to achieve full hemostasis.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
Group 2: Vaso-band Arm
n=126 participants at risk
Patients will receive Vaso-band (VasoInnovations, Inc, USA), applied with ulnar balloon inflated with 15 ml of air, and the radial balloon inflated after the sheath is removed, to apply optimal pressure for obtaining full hemostasis. Ulnar balloon will be deflated after 60 minutes of radial artery hemostatic compression.
VasoBand: Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
|
|---|---|---|
|
Surgical and medical procedures
Forearm Hematoma
|
4.7%
6/127 • Number of events 6 • The event of Forearm Hematoma was assessed in the time period of the procedure, from the point of obtaining arterial access to the point of discharge from the catheterization laboratory, up to 4 hours or similar The event of Rebound Bleeding was assessed in the time period after removal of hemostatic compression band up to 1 hour or similar which is typically 4 hours or similar from the time of arterial puncture.
Forearm Hematoma is a new swelling in the forearm as a result of bleeding Rebound Bleeding is bleeding restarting at the access site after hemostasis was achieved
|
0.00%
0/126 • The event of Forearm Hematoma was assessed in the time period of the procedure, from the point of obtaining arterial access to the point of discharge from the catheterization laboratory, up to 4 hours or similar The event of Rebound Bleeding was assessed in the time period after removal of hemostatic compression band up to 1 hour or similar which is typically 4 hours or similar from the time of arterial puncture.
Forearm Hematoma is a new swelling in the forearm as a result of bleeding Rebound Bleeding is bleeding restarting at the access site after hemostasis was achieved
|
|
Surgical and medical procedures
Rebound Bleeding
|
7.9%
10/127 • Number of events 10 • The event of Forearm Hematoma was assessed in the time period of the procedure, from the point of obtaining arterial access to the point of discharge from the catheterization laboratory, up to 4 hours or similar The event of Rebound Bleeding was assessed in the time period after removal of hemostatic compression band up to 1 hour or similar which is typically 4 hours or similar from the time of arterial puncture.
Forearm Hematoma is a new swelling in the forearm as a result of bleeding Rebound Bleeding is bleeding restarting at the access site after hemostasis was achieved
|
1.6%
2/126 • Number of events 2 • The event of Forearm Hematoma was assessed in the time period of the procedure, from the point of obtaining arterial access to the point of discharge from the catheterization laboratory, up to 4 hours or similar The event of Rebound Bleeding was assessed in the time period after removal of hemostatic compression band up to 1 hour or similar which is typically 4 hours or similar from the time of arterial puncture.
Forearm Hematoma is a new swelling in the forearm as a result of bleeding Rebound Bleeding is bleeding restarting at the access site after hemostasis was achieved
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place