Aorfix Intelliflex First in Human Study (FIH-NZ)

Lombard Medical

Status: Unknown

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Endovascular aneurysm repair EVAR

Study type: Observational

Funder types: Industry

Identifiers

NCT02907762

2015-07

Details and patient eligibility

About

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°.

Enrollment: 10 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.