Randomized Study of Accelerated Radial Arterial Hemostasis

Study Overview
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Brief Summary
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Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

Detailed Description
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The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, & N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.

Official Title
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Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention

Conditions
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Hemostasis

Intervention / Treatment
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* Device: hm-P bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 patients, randomized into one of three arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Full Inflation<br>100% TR Band inflation relative to recommended inflation with 15-18 cc air injected in TR band bladder | Device: hm-P bandage<br>* hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.<br>|
| Other: Mid Inflation<br>75% TR Band inflation relative to recommended inflation with 11-14 cc air injected in TR band bladder | Device: hm-P bandage<br>* hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.<br>|
| Other: Low Inflation<br>50% TR Band inflation relative to recommended inflation with 8-9 cc air injected in TR band bladder | Device: hm-P bandage<br>* hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis | Significant change in time to hemostasis | 60 minutes | 
| Compressive Force | Change in the compressive force onto the access site | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial Artery | Evaluation of the radial artery post hemostasis by visual or reverse Barbeau test | immediately after hemostasis |