Coronary Artery Disease Clinical Trial
— Statseal IIOfficial title:
Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT) II
Verified date | March 2021 |
Source | VA Long Beach Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transradial procedures. It is believed that the use of both devices in combination compared to the hemostasis band (TR band) alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that you would need to wear the hemostasis band.
Status | Completed |
Enrollment | 443 |
Est. completion date | December 15, 2020 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient undergoing diagnostic angiography or PCI via the radial artery - Patients with a Barbeau test prior to the procedure showing pattern A,B,or C. Exclusion Criteria: any one of the following... - Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed). - Use of a hemostasis method or device besides the TR Band. - Patients undergoing catheterization from the femoral, brachial, ulnar, or distal radial (snuffbox) artery approach. - Use of an anticoagulant other than unfractionated heparin or bivalirudin. - Any use of glycoprotein inhibitors or cangrelor. - Use of sheathless guides. - Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion. - Any active treatment with oral anticoagulants continued during course of procedure. - Presence of arteriovenous dialysis fistula in the ipsilateral arm. - Any physical deformity or trauma / injury of either wrist that would prevent proper placement or function of the hemostasis band. - Raynaud's syndrome or known peripheral vascular disease of the forearm. - Inability of the patient to personally consent for the study. (no surrogate consent) - History or presence of Radial Artery Occlusion. - Barbeau test showing Pattern D. - Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure. |
Country | Name | City | State |
---|---|---|---|
United States | Veteran Affairs Long Beach | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
VA Long Beach Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Hemostasis using the Hemostasis Management System (HMS) | Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. | |
Secondary | Percent of patients with radial artery occlusion (RAO) | Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. |
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