Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03028025
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2017-01-13
Brief Title:
Comparing TR Band to Statseal in Conjunction With TR Band
Sponsor:
VA Long Beach Healthcare System
Organization:
VA Long Beach Healthcare System
Study Overview
Official Title:
Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch Statseal the Randomized Controlled Statseal With TR Band Assessment Trial STAT
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
This study is a physician initiated prospective observational two arm randomized study to be performed at up to four experienced Radial First centers UCSD UCLA Arkansas Heart Hospital and LBVA A maximum of 180 patients having undergone successful radial catheterization will be enrolled in the study 60 in each arm 60 patients will be enrolled at the LBVA Enrollment will continue at each site on discretion of the investigators until each center enrolls a minimum of 30 patients or a maximum of 180 patients are enrolled Clinicians will perform the catheterization in accordance with local standard practice with a minimum of 5000 units of unfractionated heparin for anticoagulation At the start of the TRA procedure prior to radial artery cannulation a baseline Pleth-ox exam will be performed for all patients and recorded on the CRF Ulnar compression will be applied to confirm that the radial artery is patent Patients with a type D pattern exam will be excluded from the study At the conclusion of a successful transradial procedure the patient will be randomized to either SSA or TRB each device applied per protocol IFU It is hypothesized that if radial artery compression time can be shortened to 40 minutes or less the following could result improved catheterization lab efficiency greater patient satisfaction and lower complication rates including RAO may be improved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None