Aorfix Intelliflex First in Human Study (FIH-NZ)

October 25, 2021 updated by: Lombard Medical

Aorfix™ Generation IV Delivery System "IntelliFlex™" Study

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°.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Successful Implant Delivery (30d)
Time Frame: 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.
1 Month
Number of participants with Treatment Success (1year)
Time Frame: 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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lombard Medical

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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