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Aorfix Intelliflex First in Human Study (FIH-NZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02907762
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Lombard Medical

Brief Summary:
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Device: Endovascular aneurysm repair EVAR

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources


Intervention Details:
    Device: Endovascular aneurysm repair EVAR
    Other Name: Aorfix Intelliflex


Primary Outcome Measures :
  1. Number of participants with Successful Implant Delivery (30d) and Treatment Success (1year) [ Time Frame: 12 Months ]

    Successful implant delivery is also called Primary Technical Success, defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, Type I or III endoleaks or graft limb obstruction. Treatment success, or Clinical Success should requires successful deployment of the endovascular device at the intended location without death as a result of aneurysm-related treatment, type I or III endoleak, graft infection or thrombosis, aneurysm expansion (diameter >=5 mm, or volume >=5%), aneurysm rupture, or conversion to open repair.

    The numbers of participants having Primary Technical Success on completion of the index procedure and Clinical Success 12 months after the procedure will be recorded.




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
  2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.
Criteria

Inclusion Criteria:

  1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.
  2. Intention to electively implant the Aorfix™ Stent Graft System with IntelliFlex™ Delivery Device.

Exclusion Criteria:

  1. Do not comply with the indications for Aorfix™ in the IFU.
  2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care of the investigative site.
  3. Unwillingness or inability to provide informed consent to both the study and the EVAR procedure.
  4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.

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): NCT02907762


Sponsors and Collaborators
Lombard Medical
Investigators
Principal Investigator: Andrew Holden, MD University of Auckland, NZ

Responsible Party: Lombard Medical
ClinicalTrials.gov Identifier: NCT02907762     History of Changes
Other Study ID Numbers: 2015-07
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016

Keywords provided by Lombard Medical:
Endovascular
EVAR
Neck Angulation

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases