- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05468957
Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure
July 28, 2023 updated by: Rushi V. Parikh, University of California, Los Angeles
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
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David M Tehrani, MD MS
- Phone Number: 310-206-6286
- Email: dtehrani@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Recruiting
- UCLA Ronald Reagen
-
Contact:
- David
- Phone Number: 310-206-6286
- Email: dtehrani@mednet.ucla.edu
-
Los Angeles, California, United States, 90025
- Recruiting
- UCLA Santa Monica
-
Contact:
- David Tehrani, MD MS
- Phone Number: 310-206-6286
- Email: dtehrani@mednet.ucla.edu
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Perclose Only
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.
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.
Other Names:
|
Experimental: Perclose with Statseal Device
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.
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Ambulation
Time Frame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
|
From the time of manual compression after PercloseTM deployed until ambulation is initated after hemostasis is achieved.
|
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Discharge
Time Frame: At least 15 minutes after abultation occurs for those in the outpatient setting.
|
From the time of manual compression after PercloseTM deployed until discharge order is activated.
|
At least 15 minutes after abultation occurs for those in the outpatient setting.
|
Time to hemostasis
Time Frame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
|
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
|
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
|
Percent of patients with hematoma
Time Frame: Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
|
Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging.
|
Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
July 18, 2022
First Submitted That Met QC Criteria
July 20, 2022
First Posted (Actual)
July 21, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 28, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-000700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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