OPEN-Radial: Patent Hemostasis With Vasoband Versus TR Band

• Sponsor: Total Cardiovascular Solutions (Other)
• Overall Status: Completed
• CT.gov ID: NCT04002791
• Collaborator: (none)
• Enrollment: 253
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 36

Study Details

Study Description

Brief Summary

In patients referred for cardiac catheterization to be performed using transradial access, a randomized comparison will be performed with the primary endpoint of patency of radial artery at the time of application of hemostatic compression band. The single radial only TR-Band (Terumo, Japan) will be compared to the dual balloon Vasoband (Vasoinnovations, USA) capable of ipsilateral ulnar artery compression.

Condition or Disease	Intervention/Treatment	Phase
Radial Artery Injury at Wrist and Hand Level	Device: VasoBand	N/A

Detailed Description

Introduction:

TRA is increasing in utilization across the world due to its established benefits of reduction in access site complications, cost, and increase in patient comfort (1). The most common structural consequence of TRA is radial artery occlusion (RAO). It occurs in 2-10% of patients undergoing TRA (2). Several pharmacologic as well as non-pharmacologic practices have been associated with RAO. Maintaining a hardware profile smaller than the inner diameter of radial artery has been associated with better radial artery patency rates after the procedure (3). Use of unfractionated heparin and other parenteral anticoagulants administered during the procedure has also been associated with reduction in RAO, with a dose-dependent effect with better reduction with higher doses of heparin (4,5).

One of the most effective intervention for reduction of RAO is avoidance of flow cessation in radial artery during hemostatic compression (6). This technique, called "patent hemostasis", has been shown to unequivocally and sizably reduce the incidence of RAO. In patients with small diameter radial arteries as well as low blood pressures, the ability to achieve and maintain patent hemostasis has been observed to be lower than those otherwise. In view of the co-dominant nature of forearm arterial circulation, the radial and ulnar arteries are interdependent and compression of ipsilateral ulnar artery has been shown to increase flow as well as peak flow velocity in the radial artery (7). Ipsilateral ulnar artery compression during hemostatic compression of a punctured radial artery, has been shown to sizably and significantly reduce the incidence of RAO compared to patent hemostasis (8). Randomized and observational datasets utilizing this technique published so far have been using two devices to achieve radial and ulnar compression, with difficult ergonomics leading to frequent dislodgment of ulnar compression during the radial artery hemostatic process.

The investigators intend to study the comparative efficacy of the first dedicated dual compression device in achieving patent hemostasis compared to the current popular radial artery compression device.

Patients and Methods:

Patients referred for diagnostic cardiac catheterization using TRA will be screened. Those providing written informed consent, will be enrolled in the study. A transradial cardiac catheterization will be performed using the standard technique as described below.

Catheterization Technique:

After sterile preparation as well as local anesthetic infiltration, 5 French hydrophilic introducer sheath will be introduced in the radial artery using standard puncture technique (9). Once the introducer is in the radial artery lumen, 200 µg of nitroglycerin, 2.5 mg of verapamil and 5000 IU of unfractionated heparin will be administered intra-arterially. 5 French or lower profile hardware will be used as per operator discretion to complete the procedure.

Once the procedure is completed, the patient will be randomized to:

Group 1, which will include patients receiving 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 to achieve full hemostasis.

Group 2, will consist of patients who will receive Vaso-band (VasoInnovations, Inc, USA), applied according to instructions for use, with ulnar balloon inflated for the first 60 minutes of radial artery hemostatic compression, with the radial balloon inflated to obtain full hemostasis, after the sheath is removed.

Primary Study End-point: Radial artery patency at 0-15 minutes after application of radial artery hemostatic compression.

Monitoring of Patency:

The radial artery patency will be monitored immediately after application of the band using reverse Barbeau test in both groups, and patency will be re-evaluated at 15 minutes after band application, 30 minutes after band application, 60 minutes after band application, as well as upon removal of the band at 120 minutes.

If longer duration of application of pressure with the band is necessary in either group to achieve hemostasis, the bands will be applied for longer duration and the adequacy of hemostasis will be evaluated every 15 minutes after 120-minute duration and the band removed once adequately adequate hemostasis has been achieved.

Radial patency will be assessed at 60 minutes after the band is removed.

Baseline demographic as well as procedural data, pharmacologic data, as well as elaborately data will be collected on every patient.

Statistical Analysis Plan:

Categorical variables will be expressed as proportions, and differences between the two groups will be assessed using chi-square test, or Pearson test as deemed appropriate. Numeric variables will be assessed for normality of the distribution, and will be expressed as mean and standard deviation for normally distributed variables, and median as well as interquartile range for those without normal distribution. Parametric tests will be used to compare differences between the two groups for normally distributed numeric variables, and nonparametric tests will be used in those variables with a non-normal distribution. Multivariable analysis if necessary, will be performed using forward selection binary logistic regression for categorical dependent variable and linear regression for numeric variables. Received operative characteristic derived c-statistic will be used to assess the stability of the model.

Sample Size Calculation:

Based on the available literature, using the current standard of care TR band, patent hemostasis defined as patency of radial artery during hemostatic compression at 15 minutes into compression is achievable in 75% of patients undergoing TRA. The only published randomized trial using prophylactic ipsilateral ulnar artery compression during radial artery hemostatic compression has shown 96% achievement of patent hemostasis at 15 minutes after onset of compression. Using this using these data, using a chi-square model, a sample size of 250 to 300 patients equally divided between two groups, is necessary to achieve a 90% power with an alpha editor of 0.05. Expecting a 10% crossover rate will be accommodated a sample size of 200 patients will be needed. After randomizing 200 patients, an interim analysis will be performed. If event rates are low, the sample-size will be increased to 350 patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 253 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized comparison of patent hemostasis achievement with single bladder radial artery compression device with a dual-bladder ulnar compression capable radial artery compression device.Randomized comparison of patent hemostasis achievement with single bladder radial artery compression device with a dual-bladder ulnar compression capable radial artery compression device.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Patent Hemostasis: OPEN-Radial Trial
• Actual Study Start Date: Mar 16, 2019
• Actual Primary Completion Date: Oct 16, 2019
• Actual Study Completion Date: Oct 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Device: VasoBand; Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
Active Comparator: 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.	Device: VasoBand; Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression

Outcome Measures

Primary Outcome Measures

1. Number of Patients Who Achieved Patent Hemostasis [0-15 minutes]

   Patent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression

Secondary Outcome Measures

1. Number of Participants With Radial Artery Occlusion One Hour After Removal of Hemostatic Compression [0-60 minutes]

   Absence of Patency of radial artery at 1-hour after removal of hemostatic compression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients referred for cardiac catheterization undergoing transradial access

Exclusion Criteria:

• Previous ipsilateral radial artery cannulation, oral systemic anticoagulation therapy, thrombolytic therapy in the previous 7 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Apex Heart Institute	Ahmedabad	Gujarat	India

Sponsors and Collaborators

• Total Cardiovascular Solutions

Investigators

• Principal Investigator: Tejas M Patel, MD, Apex Heart Institute, Ahmedabad, India

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2019

More Information

Publications

None provided.

• Responsible Party: Total Cardiovascular Solutions
• ClinicalTrials.gov Identifier: NCT04002791
• Other Study ID Numbers: A98
• First Posted: Jul 1, 2019
• Last Update Posted: Nov 13, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Arm/Group Title	Group 1: TR Band Arm	Group 2: Vaso-band Arm
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	127	126
COMPLETED	127	126
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1: TR Band Arm	Group 2: Vaso-band Arm	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	127	126	253
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (10)	59 (11)	58 (10.7)
Sex: Female, Male (Count of Participants)
Female	39 30.7%	33 26.2%	72 28.5%
Male	88 69.3%	93 73.8%	181 71.5%
Race/Ethnicity, Customized (Count of Participants)
INDIAN	127 100%	126 100%	253 100%
Hypertension (Count of Participants)
Count of Participants [Participants]	80 63%	79 62.7%	159 62.8%
Diabetes (Count of Participants)
Count of Participants [Participants]	49 38.6%	46 36.5%	95 37.5%
Previous PCI (Count of Participants)
Count of Participants [Participants]	12 9.4%	12 9.5%	24 9.5%
Previous CABG (Count of Participants)
Count of Participants [Participants]	1 0.8%	4 3.2%	5 2%
Height (Centimeter) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Centimeter]	165	165	165
Weight (Kilograms) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Kilograms]	72	71	71
Hemoglobin (Gram/Dl) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Gram/Dl]	13.5	13.2	13.3
Platelets (Cells x1000/ml) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Cells x1000/ml]	270	250.5	261
Serum Creatinine (mg/dl) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dl]	0.91	0.91	0.91
Wrist Circumference (cm) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cm]	21	20	20
Barbeau Test Pattern A (Count of Participants)
Count of Participants [Participants]	70 55.1%	75 59.5%	145 57.3%
Barbeau Test Pattern B (Count of Participants)
Count of Participants [Participants]	53 41.7%	46 36.5%	99 39.1%
Barbeau Test Pattern C (Count of Participants)
Count of Participants [Participants]	4 3.1%	5 4%	9 3.6%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Who Achieved Patent Hemostasis
Description	Patent hemostasis achievement at 0-15 minutes after onset of radial artery hemostatic compression
Time Frame	0-15 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: TR Band Arm	Group 2: Vaso-band Arm
Arm/Group Description	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	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
Measure Participants	127	126
Count of Participants [Participants]	94 74%	122 96.8%

2. Secondary Outcome

Title	Number of Participants With Radial Artery Occlusion One Hour After Removal of Hemostatic Compression
Description	Absence of Patency of radial artery at 1-hour after removal of hemostatic compression
Time Frame	0-60 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: TR Band Arm	Group 2: Vaso-band Arm
Arm/Group Description	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	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
Measure Participants	127	126
Count of Participants [Participants]	13 10.2%	2 1.6%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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
Arm/Group Title	Group 1: TR Band Arm		Group 2: Vaso-band Arm
Arm/Group Description	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		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
All Cause Mortality
	Group 1: TR Band Arm		Group 2: Vaso-band Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/126 (0%)
Serious Adverse Events
	Group 1: TR Band Arm		Group 2: Vaso-band Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/127 (12.6%)		2/126 (1.6%)
Surgical and medical procedures
Forearm Hematoma	6/127 (4.7%)	6	0/126 (0%)	0
Rebound Bleeding	10/127 (7.9%)	10	2/126 (1.6%)	2
Other (Not Including Serious) Adverse Events
	Group 1: TR Band Arm		Group 2: Vaso-band Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/126 (0%)

Limitations/Caveats

Single-center, single-country study

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.