At a glance

ClinicalIndex Comparison Record

N/ACompleted· 184 enrolled

Drug / intervention

StatSeal +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03028025

NCT03028025N/ACompleted

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Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)

VA Long Beach Healthcare System·interventional·Posted Jan 23, 2017·Updated Apr 21, 2021

In Brief

A clinical study evaluating StatSeal and TR Band for Arterial Occlusion and 6 related conditions. Completed, enrolled 184 participants across 1 site.

Detailed Summary

The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs first, and the Time to Hemostasis (TTH).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsArterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-Induced Bleeding, Coronary Artery Disease

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

Enrollment StartJan 2017

First PostedJan 2017

Primary CompletionAug 2017

TodayJul 2026

First PostedJan 23, 2017

Enrollment StartJan 1, 2017

Primary CompletionAug 1, 2017

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 9.4 years ago

Interventions

StatSealdevice

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.

TR Banddevice

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.