Trial Outcomes & Findings for Transradial-Band Pilot Study (NCT NCT04709341)

NCT ID: NCT04709341

Last Updated: 2025-04-06

Results Overview

Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

an average of 12 hours post procedure

Results posted on

2025-04-06

Participant Flow

The study was conducted at MUSC's VIR Department, including University Hospital and outpatient clinics. Patients scheduled for angiographic procedures were screened for eligibility via Barbeau tests, ultrasounds, and lab reviews. Informed consent was obtained during consultations or in recovery bays. Recruitment involved 30 randomized patients divided into expedited and standard protocol groups.

No significant events, such as washout or run-in periods, occurred after participant enrollment and before group assignment. All participants who met eligibility criteria, including acceptable Barbeau test results, ultrasound evaluation, and coagulation parameters, were randomized directly into the expedited or standard protocol groups. No exclusions were reported after enrollment and prior to randomization

Participant milestones

Participant milestones
Measure	Group A TR Band 60MIN: TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals	Group B TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transradial-Band Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=15 Participants TR Band 60MIN: TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals	Group B n=15 Participants TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	61.5 years STANDARD_DEVIATION 16.67 • n=5 Participants	64.2 years STANDARD_DEVIATION 11.7 • n=7 Participants	62.8 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: an average of 12 hours post procedure

Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma

Outcome measures

Outcome measures
Measure	Group A n=15 Participants TR Band 60MIN: TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals	Group B n=15 Participants TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Percentage of Participants With Bleeding	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Continued ooze requiring re-inflation of the TR-Band or subcutaneous ecchymosis without a discernable hematoma

Outcome measures

Outcome measures
Measure	Group A n=15 Participants TR Band 60MIN: TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals	Group B n=15 Participants TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Percentage of Participants With Bleeding	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Population: No patients presented with this symptom during the TR Band Procedure.

Reduced or absence of radial artery blood flow based on ultrasound and Barbeau test

Outcome measures

Outcome measures
Measure	Group A n=15 Participants TR Band 60MIN: TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals	Group B n=15 Participants TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Left Radial Artery Occlusion	0 Participants	0 Participants

Adverse Events

Group A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group A n=15 participants at risk TR Band 60MIN: TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals	Group B n=15 participants at risk TR Band 120MIN: TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
Musculoskeletal and connective tissue disorders Mild Bruising	6.7% 1/15 • Number of events 1 • 30 days The outcomes focus on safety, efficacy, and complications specific to the radial artery access site, and no deaths were mentioned or attributed to the procedures or protocols	0.00% 0/15 • 30 days The outcomes focus on safety, efficacy, and complications specific to the radial artery access site, and no deaths were mentioned or attributed to the procedures or protocols

Additional Information

Samuel Bidwell- Research Manager

Medical University of South Carolina

Phone: 843-792-2305

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place