Optimization of Transradial-Band Removal Following Transradial Arterial Access for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot Study)
Phase: NA
Conditions: Radial Artery Incision Site Closure
Sponsor: Medical University of South Carolina

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NCT04709341 
Optimization of Transradial-Band Removal Following Transradial Arterial Access 
for Interventional Radiology Diagnostic and Interventional Procedures (A Pilot 
Study) 
 

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PROTOCOL TITLE: 
 
Optimization of Trans-Radial (TR)-Band Removal Following Transradial Arterial 
Access for Interventional Radiology Diagnostic and Interventional Procedures (a 
pilot study) 
 
 
PRINCIPAL INVESTIGATOR: 
 
Ricardo Yamada, MD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Objectives/Specific Aims 
The specific aim of the study is to evaluate the safety and efficacy of initiating earlier 
TR-Band weaning following transradial access procedures, while minimizing access site 
complications including hematoma formation and radial artery occlusion (RAO). 
 
The primary objective is to evaluate the rate and severity of complications (i.e. 
hematoma, ecchymosis and radial artery occlusion) from an expedited weaning protocol 
wherein the time to wean is reduced significantly. 
 
The secondary objective is to identify potential risks factors for complications following 
early weaning of the TR-Band. 
 
It is hypothesized that the time to wean of the TR-Band can be safely reduced while 
minimizing access site complications including hematoma formation and radial artery 
occlusion (RAO). 
 
Background 
 
The use of transradial (TR) access for the purpose of diagnosis and intervention in the 
arterial system is a well-established concept, particularly in coronary angiography, with 
many distinct advantages over conventional transfemoral (TF) access. The first series 
of 100 coronary angiographic procedures performed via TR access, published by 
Campeau in 19891, demonstrated 88% technical success rate and a 6% asymptomatic 
radial artery occlusion rate. Since then, TR access for coronary artery interventions in 
the United States has grown exponentially with the proportion of transradial 
percutaneous coronary interventions (PCI) procedures increasing from 1.2% in the first 
quarter of 2007 to 16.1% in the third quarter of 20122. And yet, its usage is largely 
absent in the interventional radiology and vascular surgery communities. Reasons for 
this include a lack of appropriate training and equipment, but the potential advantages 
of TR over TF access are abundant in both coronary and non-coronary applications. 
Firstly, the radial artery is more superficial than the femoral artery without surrounding 
neurovascular structures susceptible to injury. In addition, any sustained arterial 
damage is significantly less detrimental because of the hand’s dual arterial vascular 
supply. In addition, the radial artery is readily compressible regardless of the patient’s 
body habitus. This compressibility has been shown to decrease the incidence of post-
procedural bleeding complications as well as cardiac mortality during PCI3,4,5. In 
addition to patient safety, there are numerous benefits to overall patient comfort and 
convenience. For one, after TR access, patients may sit up in bed and ambulate 
immediately with faster discharge to home. In one randomized trial, Cooper et al 
demonstrated a strong patient preference, improved quality-of-life metrics, and 
decreased hospital costs for TR over TF access during cardiac catherization6.  
 
Ultimately, complications with TR approach have proven rare in both coronary and 
noncoronary applications. Most commonly, a local small hematoma may develop with 

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mild pain, usually treated with NSAIDS if necessary. Despite meticulous hemostatic 
technique, radial artery thrombosis may occur. Nevertheless, this thrombosis almost 
always remains asymptomatic7, at least partially because a modified Allen’s test or 
Barbeau test is performed before all procedures using TR access. Additional possible 
complications of TR access include radial artery pseudoaneurysm, spasm, dissection, 
digit ischemia, as well as cerebral infarction, but all of the following have proven to be 
extremely low incidence particularly with the usage of intraprocedural heparinization and 
vasodilators, which are included in our procedure protocol.  
 
Finally, and increasingly more important in the modern era of health care reform, TR 
access offers many benefits to hospital costs and patient satisfaction. Many studies 
have demonstrated decreased costs associated with TR versus traditional TF 
access5,8,9, primarily due to the non-utilization of arterial closure devices and decreased 
readmission for bleeding complications. International studies have long promoted TR 
access as a feasible, safe, and well tolerated method for performing hepatic 
transarterial chemoembolization10,11.  In a recent series performed in the United States, 
technical success was obtained in all procedures. Furthermore, 100% of patients who 
underwent both TF and TR access preferred TR to TF access12.  Our study seeks to 
further establish earlier TR Band deflation as a viable and preferable method following 
transarterial cases to further decrease unnecessary PACU recovery time and expenses.  
 
Intervention to be Studied 
 
TR-Band is an FDA approved device to assist achievement of hemostasis following 
redial access procedures. The TR-Band is not specifically FDA approved for the 
expedited protocol being studied here, but the standard of care FDA guidelines allow 
flexibility as need for the deflation protocol for each patient. 
 
Per MUSC standard policy, after an angiographic procedure is performed via the 
transradial approach, hemostasis at the arterial puncture site is attained using a TR-
Band (Terumo Medical Corporation, Tokyo, Japan). The TR-Band consists of a part-
rigid, Velcro-secured wristband with an inflatable bladder that provides compression of 
the radial artery when air is injected into the cuff-valve system via the supplied syringe.   
 
Per the Terumo guidelines14, to place the TR-Band, the introducer sheath in the radial 
artery is first retracted 2-3 cm and the center of the compression balloon is positioned 1-
2 mm proximal to the puncture site. The TR-Band is then affixed on the wrist with the 
adjustable Velcro fastener and 15 cc of air is injected into the cuff-valve system while 
simultaneously removing the introducer sheath. The amount of air in the compression 
balloon is subsequently titrated by removing 1 cc of air until bleeding occurs or 5 cc of 
air is removed. Once one of those two endpoints is met, 2 cc of air are injected into the 
cuff-valve system. To confirm patent hemostasis the ulnar artery at the level of the wrist 
is then compressed and the morphology of the plethysmographic waveform is observed 
– this is referred to as the reverse Barbeau’s test. Absence of a plethysmographic 
waveform indicates interruption of antegrade radial artery flow. If this occurs, the volume 

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of air in the compression balloon is again titrated until the plethysmographic waveform 
returns. 
 
The standard protocol is for the TR-Band to remain in place for 60 minutes. After 60 
minutes, 1/4 of the total volume in the TR-Band is removed at 15-minute intervals until it 
is fully deflated. 
 
The rationale for an expedited weaning protocol is based in part on the observation that 
after access of the femoral artery for an angiographic procedure the standard to attain 
hemostasis without the use of a percutaneous closure device is manual pressure at the 
puncture site for 15 minutes. Since the radial artery, in contradistinction to the femoral 
artery, is superficial and readily compressible due to the flat surface of the radius, it is 
counterintuitive that to attain hemostasis pressure at the radial puncture site, pressure 
would need to be maintained for 60 minutes. In addition, Pancholy et al concluded 
based on a retrospective study of 10 consecutive patients undergoing transradial 
coronary angiography that “shorter duration of hemostatic compression is associated 
with a lower incidence of early and chronic RAO, without increase in bleeding 
complications.” 
 
The standard of care (control) group in the study will consist of the subset of patients 
wherein the time to weaning of the TR-Band is 60 minutes. 
 
Study Endpoints 
 
The study participants will be randomly assigned into one of two groups; these groups 
will be defined based on the time from inflation to initiation of deflation of the TR-Band, 
i.e. the time to wean. 
 
Group A (Total time about 60 minutes) 
Group B (Total time about 120 minutes) 
TR-Band Placed following your procedure 
TR-Band Placed following your procedure 
After 15 minutes deflated by 1/4 
After 60 minutes deflated by 1/4 
After 25 minutes deflated by 1/2 
After 75 minutes deflated by 1/2 
After 35 minutes deflated by 3/4 
After 90 minutes deflated by 3/4 
After 45 minutes deflated completely 
After 105 minutes deflated completely 
Observe your wrist for 15 minutes 
Observe your wrist for 15 minutes 
Remove TR-Band after 60 minutes 
Remove TR-Band after 120 minutes 
 
 
 
The primary outcomes will be the incidence of significant hematomas (> 5 cm in size), 
bleeding (continued ooze requiring re-inflation of the TR-Band or subcutaneous 
ecchymosis without a discernable hematoma) and occlusion of the left radial artery 
(based on ultrasound) at the procedure visit and at one month follow up visit 
 
Inclusion and Exclusion Criteria/Study Population 

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Each patient will be screened prior to the procedure to determine if he or she is a 
candidate for trans-radial access. The screening process will consist of a Barbeau’s test 
wherein a plethysmographic sensor is placed on the thumb or index finger of the upper 
extremity to be used during the procedure and the radial and ulnar arteries are 
simultaneously compressed. Once the pc waveform is absent, the pressure on the ulnar 
artery is released and the plethysmographic waveform is observed. Based on the 
morphology of the plethysmographic waveform, the patients are subdivided into 4 types: 
types A through C are considered candidates for transradial access while type D is 
considered a contraindication. As part of the screening process the patient’s radial 
artery will also be evaluate with ultrasound to ensure that the diameter of the vessel is 
greater than or equal to 1.6 mm. The coagulation parameter of the patients, in particular 
the platelet count, INR and prothrombin time. In addition, due to inherent risk of 
radiation exposure associated with the angiographic procedure all premenopausal 
female patients will be screened with a urine hCG test. 
 
To be included in the study patients will need to be:  
• Age 18 years and older 
• Have an acceptable Barbeau test (i.e. type A through C) 
• Have acceptable coagulation parameters (based on PT, INR, platelet count, and 
appropriate pre-procedural management of anticoagulants, See Table 1) 
• The caliber of the radial artery based on a pre-procedure sonographic evaluation 
will need to be greater than or equal to 1.6 mm.  
• The appropriate pre-procedural management of anticoagulants is based on the 
consensus guidelines established by Patel et al16.  
 
 
Lab 
Acceptable Range 
INR 
Less than 1.5 
Platelet count 
Greater than 50,000 
platelets/L 
Prothrombin 
Time 
Less than 15 seconds 
 
Table 1. Acceptable Ranges of PT, INR and platelet count. 
 
Patients will be excluded from the study if: 
 
• If there is an unacceptable risk of bleeding diathesis, or  
 
• If he or she is not a suitable candidate for transradial access based on a Barbeau 
test type D or a diameter of the left radial artery less than 1.6 mm.  
 
There will be no exclusions based on gender/sex or race/ethnicity of the study 
participant. 
 

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Number of Subjects 
 
The study cohort will consist of up to 30 enrolled and randomized patients age 18 years 
and older who undergo an angiographic procedure via the radial artery. The proposed 
study does not include children. 
 
Setting 
 
The setting of the study will be the Vascular and Interventional Radiology (VIR) 
Department at the Medical University of South Carolina. The VIR Department performs 
procedures at both the University Hospital and the Ashley River Tower. In addition, Dr. 
Yamada has weekly outpatient clinics at the North Charleston Medical Pavilion (8992 
University Boulevard, North Charleston, SC 29406) and East Cooper Medical Pavilion 
(1600 Midtown Avenue, Mount Pleasant, SC 29464). 
 
Recruitment Methods 
 
Subjects scheduled for angiographic procedures will be asked by the PI, Co-I or IRB 
approved study team members to participate in the trial. Eligibility will be determined by 
laboratory test and medication review. 
 
Consent Process 
 
Once a patient is referred to Vascular and Interventional Radiology for consultation of 
an angiographic procedure that could be performed via the left or right radial artery, the 
patient will be informed of the study design by the PI, Co-I or IRB approved study team 
members. Some consents may be obtained prior to this during the initial consultation, 
but due to COVID precautions, consultations are mostly being conducted via 
telemedicine. We are not seeking obtain consent via tele methods. The recovery bay is 
great place to conduct this discussion due to privacy and that family members are often 
present. Patients are in prep bay for up to and over an hour prior to the procedure. The 
relative risks, benefits, and alternatives of the different approaches to attain hemostasis 
will also be discussed in detail. Informed consent will be obtained and appropriately 
documented in the patient’s medical records. During the informed consent, it will be 
emphasized that regardless of the approach to hemostasis, the technical success of the 
intended procedure should not be affected.  
 
The consent will be obtained at the time of the initial consultation. As stated above, no 
patients less than 18 years of age will be included in the study. On the day of the 
procedure, the design of the study and the relative risks, benefits, and alternatives of 
the different approaches to attain hemostasis will again be discussed in detail with the 
patient or patient’s next of kin/medical power of attorney.  
 
Study Design/Methods 
 

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Following approval of the methodology by IRB we will conduct a randomized, single 
center study of up to 30 subjects who undergo an angiographic procedure via the radial 
artery. Those patients who meet the inclusion criteria will be randomly assigned to one 
of two groups (A or B) based upon a standard randomized process using pre-
designated sealed envelopes.  
 
Pre-procedure, all patients participating in the study will be evaluated with a Barbeau 
test and a sonogram of the radial artery to determine the caliber of the vessel (in mm) 
and the distance (in mm) from anterior wall of the vessel to the skin surface. In addition, 
updated INR, PT and platelet count (within 14 days) and if applicable pre-procedure 
management of anticoagulants will be reviewed. All these variables will be documented 
in the TR-Band Form. 
 
 
Intra-procedure, all patients participating in the study will receive conscious sedation 
with midazolam and fentanyl - dosage at the discretion of the operator. Once the area 
around the puncture site is infiltrated with less than 1 mL of 1% lidocaine, the radial 
artery will be cannulated with a 21-gauge needle using a modified Seldinger technique 
(i.e. a single wall puncture). The needle will subsequently be exchanged over a 0.021-
inch wire for a hydrophilic-coated 5 Fr x 10 cm Glidesheath Slender sheath. Patients will 
then receive 200 micrograms of intra-arterial nitroglycerin and an initial bolus of 3000-
5000 units of intra-venous heparin. Of note, patients undergoing a transradial uterine 
artery embolization will also receive 2.5 mg of intra-arterial verapamil. During the 
procedure patients will receive additional boluses of 1000 units of intra-venous heparin 
at 30-minute intervals. Prior to removal of the sheath, a second dose of 200 micrograms 
of intra-arterial nitroglycerin will be administered and an ACT value will be measured. 
After the sheath is removed, hemostasis will be attained with a TR-Band. The TR-Band 
consists of a part-rigid, Velcro-secured wristband with an inflatable bladder that provides 
compression of the radial artery when air is injected into the cuff-valve system via the 
supplied syringe. 
 
Group A (Total time about 60 minutes) 
Group B (Total time about 120 minutes) 
TR-Band Placed following your procedure 
TR-Band Placed following your procedure 
After 15 minutes deflated by 1/4 
After 60 minutes deflated by 1/4 
After 25 minutes deflated by 1/2 
After 75 minutes deflated by 1/2 
After 35 minutes deflated by 3/4 
After 90 minutes deflated by 3/4 
After 45 minutes deflated completely 
After 105 minutes deflated completely 
Observe your wrist for 15 minutes 
Observe your wrist for 15 minutes 
Remove TR-Band after 60 minutes 
Remove TR-Band after 120 minutes 
 
 
If bleeding were to occur, the TR-Band will be re-inflated to the previous volume and the 
weaning protocol will be restarted after 15 minutes. Once the TR-Band is removed the 
patient will be re-evaluated for complications including hematoma, ecchymosis and 
occlusion. 
 

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Post-procedure, patients will return to the clinic 1 month following their procedure and 
be re-evaluated for radial access complications including hematoma, ecchymosis and 
occlusion; and for re-evaluation of the Barbeau test, and ultrasound.  
 
 
Data Management 
 
The data from living human subjects will include the physical examination, 
laboratory, and ultrasound data collected both immediately before and after the 
procedure; these include the pre-procedure History and Physical note, the procedure 
report, nursing notes and clinic Progress notes. 
 
Only IRB approved team members will have access to the records of the patient’s 
involved, which should be effective in controlling the confidentiality of the study. 
Individual, unique patient codes will be utilized in an Excel data spreadsheet for 
anonymization and subsequent analysis. These patient codes will be stored in a 
separate, secure location at the VIR Research Coordinator Office. The patient’s 
safety will be ensured by the following methods. Prior to discharge from the PACU 
the patients will be given the contact information of the VIR Nurse Coordinator and 
clinic for any concerns. In addition, in the case of emergency, a VIR team of 
physicians and staff are on call at all times (24/7) to manage any acute or emergent 
patient issues. 
 
The patients’ characteristics (e.g. demographic information) will be compared using 
a t-test or chi-squared tests. The primary outcomes, i.e. rates of complications will 
be compared using a McNemar’s test.  An odds ratio will be estimated and its 95% 
confidence interval reported. Associations between preoperative factors and 
complications will be evaluated using logistic regression with random effects to 
account for multiple observations per patient. 
 
Risks to Subjects 
 
The potential risks to subjects for both groups include access site hematoma, pain, 
radial artery occlusion, and prolonged PACU recovery time. Potential transradial 
procedural related complications including pseudoaneurysm, digital ischemia, and 
arterial dissection are not inherently related to the timing of TR-Band deflation. 
 
Per institutional protocol, the subjects will receive standard of care treatment as any 
similar patient in the same clinical scenario. Each planned procedure will involve a 
preprocedural evaluation including a sonogram of the radial artery that will be 
accessed during the procedure and Barbeau test conducted by the co-investigators 
under the supervision of the principal investigator. The Barbeau test will serve to rule 
out vascular compromise that may occur in the absence of sufficient vascular 
pressure. Not subject will be discharged until this is confirmed. Pre- and post-
procedural laboratory values, including platelet count, activated clotting time and 
coagulation profile, will also be reviewed and analyzed. Following each procedure, 

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the subjects will be monitored for any immediate adverse events per the standard of 
care. As stated above, following discharge, the patient will be provided instructions 
as well as the contact information of the Nurse Coordinator for routine scheduling 
and care issues. In the case of an emergency, a Vascular and Interventional 
Radiology team of physicians and staff are on call 24 hours to manage any acute or 
emergent patient issues. All adverse events will be monitored, resolved, and 
recorded in the patient’s medical record. Each case will be review by PI or Co-I and 
IRB approved study staff to evaluate unanticipated problems or adverse events. 
These will be reported to IRB within 10 business days. An experienced VIR nurse, 
Megan Shinner will serve and independent evaluator of each case to determine if 
unanticipated problem and adverse even might warrant the cessation of the study. 
The independent evaluator is not part of the IRB approved study team and will not 
be part of the publication of the findings. She will remain blinded to the unique study 
ID and will only have access to standard of care procedures and non-study data. 
 
There is also a risk of loss of confidentiality. Being randomized to the expedited 
deflation group may be an additional risk. 
Sharing of Results with Subjects 
Individual test results, diagnostic tests and incidental findings will not be shared with 
subjects or others (e.g. the subject’s primary care physicians). 
Potential Benefits to Subjects or Others 
 
The potential benefits to the patients include a shorter PACU recovery times, less 
postoperative discomfort related to the insufflated TR-Band, and lower cost. The 
preoperative physical, laboratory and ultrasound examination will also help to clarify 
patient criteria for indications and contraindications for Expedited TR Band deflation 
by identifying demographic and anatomic risk factors for complications.  
 
Drugs or Devices 
There no drug or devices that will be used for this study that are outside what is 
used for the standard of care. 
 
 
References 
 
Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet 
Cardiovasc Diagn. 1989; 16:3-7. 
 
Feldman DN, et al. Adoption of radial access and comparison of outcomes to 
femoral access in percutaneous coronary intervention: an updated report from the 
national cardiovascular data registry (2007-2012). Circulation. Jun 11 
2013;127(23):2295-306.  
 

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Romagnoli E, et al. Radial versus femoral randomized investigation in ST-segment 
elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral 
Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am 
Coll Cardiol. 2012;60:2481-2489.  
 
Mehta SR, et al. Effects of radial versus femoral artery access in patients with acute 
coronary syndromes with or without ST-segment elevation.J Am Coll Cardiol. 
2012;60:2490-2499.  
 
Cooper CJ et al. Effect of transradial access on quality of life and cost of cardiac 
catheterization: a randomized comparison. AM Heart J 1999;138 (3 Pt 1):7. 
 
Benamer H, et al. A multicenter comparison of transradial and transfemoral 
approaches for coronary angiography and PTCA in obese patients: the TROP 
registry. EuroIntervention. 2007;3:327-332.  
 
Pancholy SB, et al. Effect of duration of hemostatic compression on radial artery 
occlusion after transradial access. Cathet Cardiovasc Intev. 2012; 35:1242-1244.  
 
Corvoisier PL et al. Ambulatory transradial percutaneous coronary intervention: a 
safe, effective and cost-saving strategy. Catheter Cardiovasc Interv. 2013;81:15-23. 
 
Mitchell MD, et al. Systemic review and cost-benefit analysis of radial artery access 
for coronary angiography and intervention. Circ Cardiovasc Qual Outcomes. 
2012;5:454-462. 
 
Shiozawa S, et al. Transradial approach for transcatheter arterial 
chemoembolization in patients with unresectable and recurrent hepatocellular 
carcinoma—a comparison with a conventional transfemoral approach. Gan To 
Kagaku Ryoho. 2007; 34(12):2096-8.  
 
Shiozawa S, et al. Transradial approach for transcatheter arterial 
chemoembolization in patients with hepatocellular carcinoma: comparison with 
conventional transfemoral approach. J Clin Gastroenterol. 2003;37(5):412-7.  
 
Fischman AM, et al. Transradial approach for hepatic arterial embolization: initial 
results and technique. JVIR May 2013;24(4):S93-S94.  
 
Guimaraes M, Uflacker R. “Locoregional Therapy for Hepatocellular Carcinoma.” 
Clin Liver Dis 2011 May;15(2):395-421. 
Terumo Medical Corporation. (2017). TR Band Application and Removal Guidelines 
[Brochure]. Retrieved from http://www.terumois.com/products/closure/tr-band.html 
 
Pancholy SV, Patel TM. Effect of duration of hemostatic compression on radial 
artery occlusion after transradial access. Catheter Cardiovasc Interv 2012;79:78-81. 
 

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Patel et al. Consensus Guidelines for Periprocedural Management of Coagulation 
Status and Hemostasis Risk in Percutaneous Image-guided Interventions. JVIR 
2012.