Comparing TR Band to Statseal in Conjunction With TR Band
Completed · Not applicable
Conditions studied: Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis, Hematoma, Anticoagulant-Induced Bleeding, Coronary Artery Disease
In brief
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).
Key facts
- Study ID
- NCT03028025
- Run by
- VA Long Beach Healthcare System
- People needed
- 184
- Starts
- 2017-01-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2021-04-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient undergoing diagnostic angiography or PCI via the radial artery
- Patients with a Barbeau test prior to the procedure showing pattern A,B,or
You may not qualify if…
- Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
- Use of an anticoagulant other than unfractionated heparin or bivalirudin.
- Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein inhibitors are acceptable.
- 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.
- Mental incompetence or inability to follow the instructions to complete the study.
- History or presence of Radial Artery Occlusion.
- Barbeau test showing Pattern D.
- Patients undergoing catheterization from the femoral or ulnar artery approach.
- Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.
Where it is running
- Veteran Affairs Long Beach — Long Beach, California, United States
Full record on ClinicalTrials.gov
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