Overview

This trial is active, not recruiting.

Condition aortic aneurysm, abdominal
Treatment endovascular aneurysm repair evar
Sponsor Lombard Medical
Start date November 2015
End date November 2017
Trial size 10 participants
Trial identifier NCT02907762, 2015-07

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°.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Number of participants with Successful Implant Delivery (30d) and Treatment Success (1year)
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title Aorfix™ Generation IV Delivery System "IntelliFlex™" Study
Principal investigator Andrew Holden, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Lombard Medical.