Comparing TR Band to Statseal in Conjunction With TR Band

NACompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

January 1, 2017

Primary Completion Date

August 1, 2017

Study Completion Date

August 1, 2017

Conditions
Arterial OcclusionAngina PectorisCardiovascular DiseasesAtherosclerosisHematomaAnticoagulant-Induced BleedingCoronary Artery Disease
Interventions
DEVICE

StatSeal

Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.

DEVICE

TR Band

Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.

Trial Locations (1)

90822

Veteran Affairs Long Beach, Long Beach

All Listed Sponsors
lead

VA Long Beach Healthcare System

FED

NCT03028025 - Comparing TR Band to Statseal in Conjunction With TR Band | Biotech Hunter | Biotech Hunter