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Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial

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ClinicalTrials.gov Identifier: NCT01873898
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Rex Medical

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date September 28, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • Time to Ambulation [ Time Frame: Day 0 ]
    Time to Ambulation - in minutes, defined as the time from when hemostasis is achieved to the time when ambulation is achieved (patient standing and walking at least 6.1 meters [20 feet] without re-bleeding).
  • Frequency of Major Adverse Events through 30 days [ Time Frame: 30 days ]
    The primary safety endpoint is the frequency of Major Adverse Events through 30 days, defined as one of the following events related to the use of the investigational device: a hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention or a retroperitoneal bleed.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01873898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
  • Time to Hemostasis [ Time Frame: Day 0 ]
    Time to Hemostasis - in minutes, defined as the time from when the delivery system releases both sutures, which are attached to the sealing member, to the time that hemostasis (absence of expanding or developing hematoma) is achieved
  • Placement Technical Success [ Time Frame: Day 0 ]
    Placement Technical Success - defined as the successful deployment of the device at the intended placement site such that hemostasis is achieved.
  • Clinical Success [ Time Frame: Day 0 ]
    Clinical Success - evaluated from the time of device deployment, and defined as Placement Technical Success in the absence of any major safety endpoint including subsequent hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention, or retroperitoneal bleeding.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
Official Title  ICMJE Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
Brief Summary The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with early ambulation and discharge.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Bleeding
Intervention  ICMJE Device: Rex Medical Closer™ Vascular Closure System
The Rex Medical CloserTM Vascular Closure System is currently being investigated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures or interventional procedures using up to a 7 French procedural sheath. This study will evaluate the safety and efficacy of the Rex Medical CloserTM Vascular Closure System to close the femoral artery access site of subjects who have undergone diagnostic angiography procedures with early ambulation and discharge as soon as possible after sheath removal and device placement.
Other Name: Closer™
Study Arms  ICMJE Experimental: Single Arm
This is a single arm, prospective study to collect data on the safety and effectiveness of the Rex Medical Closer™ Vascular Closure System. Only subjects who are scheduled to undergo an interventional diagnostic procedure that requires closure of the femoral access site are eligible for study participation.
Intervention: Device: Rex Medical Closer™ Vascular Closure System
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2017)
30
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is > 18 years of age.
  • Subject is able to undergo diagnostic angiography procedure and is found suitable to receive such a device at the femoral arterial puncture site in order to reduce time to hemostasis.
  • Subject or his/her legal guardian understands the nature of the procedure, and provides written informed consent prior to the procedure.
  • Subject is available and willing to participate in follow-up through 30 days post femoral closure.

Exclusion Criteria:

  • Subject with known allergies to polylactic acid (PLA), polyglycolic acid (PGA) or polydioxanone (PDO) polymers
  • Subject with severe acute non-cardiac systemic disease
  • Subject with evidence of systemic infection
  • Subject where bacterial contamination of the procedural sheath or surrounding tissues may have occurred as this may increase risk of infection
  • Subject with coagulopathy (bleeding disorders, including thrombocytopenia, hemophilia, etc.)
  • Subject taking thrombolytic medication which reduces fibrinogen to less than 100 mg/dl
  • Subject who has had a previous arterial access in the femoral artery on the treatment side with an existing hematoma >5 cm in diameter
  • Subject who is unable to ambulate at baseline
  • Subject who has had another closure device used in the treatment side within the previous 90 days
  • Subject who requires re-entry of the treatment side planned within the next 90 days post-procedure
  • Subject has a history of surgical repair on the treatment side
  • Subject has planned surgeries for any reason within 90 days post- procedure
  • Subject is pregnant or is lactating (non-pregnancy must be confirmed by testing)
  • Has a history of a psychiatric condition, substance abuse or alcohol abuse that, in the opinion of the investigator, will potentially interfere with his or her participation
  • Subject has been previously enrolled in the Rex Closer™ study
  • Subject who is currently or within the previous 4 weeks been enrolled in another investigational device or drug trial
  • Subject is incarcerated at the time of enrollment
  • Subject where the procedural sheath has been placed through the superficial femoral artery and into the profundafemoris
  • Subject where the procedure puncture site is at or distal to the bifurcation of the superficial femoral profundafemoris artery, as this may result in 1) the intravascular sealing patch catching on the bifurcation or being positioned incorrectly, and/or 2) intravascular deployment of the device into the vessel (These events may reduce blood flow through the vessel leading to symptoms of distal arterial insufficiency.)
  • Subject's procedure was accessed through a vascular graft
  • Subjects with uncontrolled hypertension (> 230 mm Hg systolic)
  • Subjects with small femoral artery size (Less than 5 mm in diameter)
  • Subjects with stenosis > 50% at the vicinity of the femoral arterial puncture site
  • Subjects with anomalous branches or vessel abnormalities present in the vicinity of the femoral arterial puncture site
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Paraguay
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873898
Other Study ID Numbers  ICMJE REX-OUS-2027-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rex Medical
Study Sponsor  ICMJE Rex Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Ebner, MD Centro de IntervencionesEndovasculares Y Cirugia Cardiovascular
PRS Account Rex Medical
Verification Date September 2017

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