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

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.

Conditions

Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Arterial Occlusion
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

Los Angeles

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

Study Record Dates

2025-07