WITHDRAWN

Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-08-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT05468957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient undergoing diagnostic angiography or PCI with femoral access who undergo PercloseTM closure.
  2. * Catheterization with a 6Fr system
  3. * 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.
  1. * Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
  2. * Patients undergoing catheterization only from the radial, brachial, ulnar, or distal radial (snuffbox) artery approach.
  3. * Use of an anticoagulant other than unfractionated heparin or bivalirudin.
  4. * Any use of glycoprotein inhibitors or cangrelor.
  5. * Use of sheathless guides.
  6. * Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
  7. * Any active treatment with oral anticoagulants continued during course of procedure.
  8. * Presence of arteriovenous dialysis fistula in the ipsilateral leg.
  9. * Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
  10. * Inability of the patient to personally consent for the study. (no surrogate consent)
  11. * Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.

Contacts and Locations

Study Locations (Sites)

UCLA Ronald Reagen
Los Angeles, California, 90025
United States
UCLA Santa Monica
Los Angeles, California, 90025
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Arterial Occlusion
  • Cardiovascular Diseases
  • Atherosclerosis
  • Hematoma