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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

Tracking Information
First Submitted Date  ICMJE July 18, 2022
First Posted Date  ICMJE July 21, 2022
Last Update Posted Date August 16, 2022
Actual Study Start Date  ICMJE August 1, 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2022)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Perclose to Statseal in Conjunction With Perclose in Femoral 6 French Arteriotomy Closure
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arterial Occlusion
  • Cardiovascular Diseases
  • Atherosclerosis
  • Hematoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Perclose
  • 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.
    Interventions:
    • Device: Perclose
    • Drug: Statseal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 20, 2022)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David M Tehrani, MD MS 310-206-6286 dtehrani@mednet.ucla.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05468957
Other Study ID Numbers  ICMJE 22-000700
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party David Tehrani, MD, MS, University of California, Los Angeles
Original Responsible Party David Tehrani, MD, MS, University of California, Los Angeles, MD MS
Current Study Sponsor  ICMJE University of California, Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP