FIH-NZ: Aorfix Intelliflex First in Human Study

Sponsor
Lombard Medical (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02907762
Collaborator
(none)
10
72

Study Details

Study Description

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 Phase
  • Device: Endovascular aneurysm repair EVAR

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
Study Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Number of participants with Successful Implant Delivery (30d) [1 Month]

    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. 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.

  2. Number of participants with Treatment Success (1year) [12 Months]

    Treatment success, or Clinical Success, 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lombard Medical

Investigators

  • Principal Investigator: Andrew Holden, MD, University of Auckland, NZ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lombard Medical
ClinicalTrials.gov Identifier:
NCT02907762
Other Study ID Numbers:
  • 2015-07
First Posted:
Sep 20, 2016
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Lombard Medical
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2021