Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Rushi V. Parikh (ucla)

Description

Summary

The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.

Official Title

A Prospective Randomized Study Comparing Time to Ambulation, Time to Hemostasis and Safety Using a Closure Device Alone an in Conjunction With a Potassium Ferrate Pad Following Transfemoral Catheterization

Keywords

Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma, Arterial Occlusive Diseases, Hemostatics, Perclose, Statseal

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient undergoing diagnostic angiography or PCI with femoral access who undergo PercloseTM closure.
  • Catheterization with a 6Fr system
  • Those with a planned radial approach will also be enrolled given the possibility of changing to femoral access in the catheterization lab if radial access is not possible given radial artery spasm, significant patient discomfort with a contraindication to greater levels of sedation, inability to transverse guidewire into the aortic root, inability to engage coronary artery or deliver equipment, or other clinically indicated reason.

You CAN'T join if...

  • Candidates for this study will be excluded if any one of the following criteria is true:
    • Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
    • Patients undergoing catheterization only from the radial, 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 leg.
    • Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
    • Inability of the patient to personally consent for the study. (no surrogate consent)
    • Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.

Locations

  • UCLA Ronald Reagen accepting new patients
    Los Angeles California 90025 United States
  • UCLA Santa Monica accepting new patients
    Los Angeles California 90025 United States

Lead Scientist at University of California Health

  • Rushi V. Parikh (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 48 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05468957
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated