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

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ClinicalTrials.gov Identifier: NCT05468957
Recruitment Status : Recruiting
First Posted : July 21, 2022
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
David Tehrani, MD, MS, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Arterial Occlusion Cardiovascular Diseases Atherosclerosis Hematoma Device: Perclose Drug: Statseal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

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.
Device: Perclose
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 Name: Suture based hemostasis device

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.
Device: Perclose
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 Name: Suture based hemostasis device

Drug: Statseal
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 Name: potassium ferrate disc with topical hydrophilic polymer




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468957


Contacts
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Contact: David M Tehrani, MD MS 310-206-6286 dtehrani@mednet.ucla.edu

Locations
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United States, California
UCLA Ronald Reagen Recruiting
Los Angeles, California, United States, 90025
Contact: David    310-206-6286    dtehrani@mednet.ucla.edu   
UCLA Santa Monica Recruiting
Los Angeles, California, United States, 90025
Contact: David Tehrani, MD MS    310-206-6286    dtehrani@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: David Tehrani, MD, MS, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05468957    
Other Study ID Numbers: 22-000700
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: August 16, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Hematoma
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hemorrhage
Pathologic Processes
Hemostatics
Coagulants