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Perclose Multi-Access DUS Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT04904809
Collaborator
(none)
36
Enrollment
2
Locations
1
Arm
8.8
Actual Duration (Months)
18
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will evaluate the safety of multiple access site closure in a single vein with the Perclose SMC by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.

Condition or Disease Intervention/Treatment Phase
  • Device: Perclose ProGlide Suture-Mediated Closure System and/or Perclose ProStyle Suture-Medicated Closure and Repair System
 N/A

Detailed Description

This study is a prospective, single-arm, US multi-center, descriptive study to evaluate the safety of multiple access site closure in a single vein with the Perclose SMC. A total of 35 subjects will be registered at 2 US investigational sites. All subjects must have femoral DUS at discharge and at a 30-day follow-up visit (if any access site-related vascular complications (either symptomatic/visible or asymptomatic/nonvisible), nerve injury, or infection at discharge, by either the investigator or the core laboratory).

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair System in Managing Multiple Venous Access Sites (Evaluation by Duplex Ultrasound)
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
May 27, 2022
Actual Study Completion Date :
May 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: All Registered Patients

All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide Suture-Mediated Closure System and/or Perclose ProStyle Suture- Mediated Closure and Repair System.

Device: Perclose ProGlide Suture-Mediated Closure System and/or Perclose ProStyle Suture-Medicated Closure and Repair System
The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Other Names:
  • Perclose ProStyle Suture-Medication Closure and Repair System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vascular Complications at Discharge [Generally within 24 hours of procedure.]

      Vascular complications detected by scheduled DUS at discharge asymptomatic/non-visible complication subjects.

    2. Vascular Complications at 30 Days [30 Days post procedure]

      Vascular complications detected by scheduled DUS at 30 days in asymptomatic/non-visible complication subjects.

    Secondary Outcome Measures

    1. All Reported Vascular Complications [Procedure to 30 days Post Procedure]

      Any vascular complications will also be analyzed as the descriptive endpoints. Vascular complications include but are not limited to: Femoral vein stenosis (> 50%) development at the puncture site related to closure technique Deep vein thrombosis in the target limb Venous bleeding, retroperitoneal bleeding Venous access site injury including vessel laceration Re-bleeding at the access site Hematoma Pseudoaneurysm AV fistula Venous tear Venous perforation Arterial tear Arterial perforation Infection Non-flow limiting suture material Access site-related nerve injury Pulmonary embolism Other (specify)

    2. Procedure Duration [Procedure]

      Length of time (in minutes) of procedure

    3. Type of procedure [Procedure]

      Cryo-ablation, RF ablation, etc.

    4. Number of Femoral Vein Access Sites Per Subject [Procedure]

      Number of Femoral Vein Access Sites Per Subject

    5. Number of Femoral Vein Access Sites Per Leg [Procedure]

      Number of Femoral Vein Access Sites Per Leg

    6. Sheath Sizes Used [Procedure]

      Sheath Sizes Used

    7. Total Number of Suture-Mediated Closure (SMC) Systems used [Procedure]

      Total Number of SMC used

    8. Number of Suture Mediated-Closure (SMC) Systems used per closure procedure [Procedure]

      Number of SMC used per closure procedure

    9. Number of Suture Mediated-Closure (SMC) Systems used per access site [Procedure]

      Number of SMC used per access site • Number of SMC used for >8F access site

    10. Number of Suture Mediated-Closure (SMC) Systems used per leg [Procedure]

      Number of SMC used per leg

    11. Device Success rate per access site [Procedure]

      Successful hemostasis without surgical conversion, or additional non-study device (adjunctive manual compression and subcutaneous stitch are regarded as the standard of care and not included as failure)

    12. Anticoagulant and antiplatelet medications [Procedure]

      Anticoagulant and antiplatelet medications used during the procedure

    13. Use of protamine for heparin reversal [Procedure]

      Protamine used for heparin reversal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥18 years

    • Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein

    • All the access sites are planned to be treated with Perclose SMC

    • Written informed consent is obtained prior to the procedure

    Exclusion Criteria:

    • Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure

    • Prior ipsilateral deep vein thrombosis within 6 months

    • International Normalization Ratio >3.5 for patients on warfarin

    • Subject who is not able to ambulate pre-procedure

    • Women who are pregnant (based on site standard pre-procedure pregnancy test)

    • Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Atlanta Georgia United States 30322
    2 St. Luke's Hospital Kansas City Missouri United States 64111

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Sanjaya K Gupta, MD, St. Luke's Hospital
    • Principal Investigator: Soroosh Kiani, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT04904809
    Other Study ID Numbers:
    • ABT-CIP-10410
    First Posted:
    May 27, 2021
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    Yes
    Keywords provided by Abbott Medical Devices
    Ablation
    Additional relevant MeSH terms:
    Arrhythmias, Cardiac

    Study Results

    No Results Posted as of Jun 21, 2022