Status:
TERMINATED
Comparing TR Band to Statseal in Conjunction With TR Band II
Lead Sponsor:
VA Long Beach Healthcare System
Conditions:
Arterial Occlusion
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at experienced 'Radial First' centers. Patients having undergone successful radial catheteriz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT04046952
Start Date
October 10 2019
End Date
December 15 2020
Last Update
November 19 2024
Active Locations (1)
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1
Veteran Affairs Long Beach
Long Beach, California, United States, 90822