Aorfix Intelliflex First in Human Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2021-11-30

Brief Summary

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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°.

Detailed Description

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Conditions

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Aortic Aneurysm, Abdominal

Keywords

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Endovascular EVAR Neck Angulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endovascular aneurysm repair EVAR

Intervention Type DEVICE

Other Intervention Names

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Aorfix Intelliflex

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, NZ

Other Identifiers

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2015-07

Identifier Type: -

Identifier Source: org_study_id