search
Back to results

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

Primary Purpose

Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perclose
Statseal
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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.

Exclusion Criteria:

- 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.

Sites / Locations

  • UCLA Ronald ReagenRecruiting
  • UCLA Santa MonicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Perclose Only

Perclose with Statseal Device

Arm Description

Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.

Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.

Outcomes

Primary Outcome Measures

Time to Ambulation
From the time of manual compression after PercloseTM deployed until ambulation is initated after hemostasis is achieved.

Secondary Outcome Measures

Time to Discharge
From the time of manual compression after PercloseTM deployed until discharge order is activated.
Time to hemostasis
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Percent of patients with hematoma
Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging.

Full Information

First Posted
July 18, 2022
Last Updated
July 28, 2023
Sponsor
University of California, Los Angeles
search

1. Study Identification

Unique Protocol Identification Number
NCT05468957
Brief Title
Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perclose Only
Arm Type
Active Comparator
Arm Description
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.
Arm Title
Perclose with Statseal Device
Arm Type
Experimental
Arm Description
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.
Intervention Type
Device
Intervention Name(s)
Perclose
Other Intervention Name(s)
Suture based hemostasis device
Intervention Description
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.
Intervention Type
Drug
Intervention Name(s)
Statseal
Other Intervention Name(s)
potassium ferrate disc with topical hydrophilic polymer
Intervention Description
Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manual pressure will be held for at least one minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. Two hours after the patient has had the PercloseTM device deployed the patient will ambulate. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held and the an ambulation trial will be attempted at least 30 minutes after the subsequent trial. This will be continued until the patient has no bleeding at the time of ambulation.
Primary Outcome Measure Information:
Title
Time to Ambulation
Description
From the time of manual compression after PercloseTM deployed until ambulation is initated after hemostasis is achieved.
Time Frame
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
Secondary Outcome Measure Information:
Title
Time to Discharge
Description
From the time of manual compression after PercloseTM deployed until discharge order is activated.
Time Frame
At least 15 minutes after abultation occurs for those in the outpatient setting.
Title
Time to hemostasis
Description
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Time Frame
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
Title
Percent of patients with hematoma
Description
Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging.
Time Frame
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. Exclusion Criteria: - 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David M Tehrani, MD MS
Phone
310-206-6286
Email
dtehrani@mednet.ucla.edu
Facility Information:
Facility Name
UCLA Ronald Reagen
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David
Phone
310-206-6286
Email
dtehrani@mednet.ucla.edu
Facility Name
UCLA Santa Monica
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tehrani, MD MS
Phone
310-206-6286
Email
dtehrani@mednet.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs