Aneurysm Treatment using the HeliFX Aortic Securement System Global Registry

Recruiting

Conditions: I71.4
Abdominal aortic aneurysm, without mention of rupture

Registration Number: DRKS00004456

Lead Sponsor: Director Clinical AffairsAptus Endosystems, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

1.Subjects with asymptomatic, symptomatic, or ruptured abdominal aortic aneurysms
2.Subject = 18 years old
3.Subject has provided written informed consent, either before or less than or equal to 30 days after the index procedure
4.Subject is willing and able to comply with standard of care follow-up evaluations
5.Subject has a previously implanted endograft (Revision Group), or will be undergoing repair (Primary Group), with one of the following abdominal aortic aneurysm endograft devices:
•Cook Zenith
•Gore Excluder
•Medtronic AneuRx
•Medtronic Talent
•Medtronic Endurant
•Any additional third party AAA endograft device that is commercially available and listed as compatible with the HeliFX system in the Instructions for Use
6.Subject’s iliac/femoral access is compatible a 16 French sheath
7.Subject that has a previously implanted endograft that has migrated or,
has a Type 1a endoleak (Revision Group) or,
will undergo implantation of an endograft that in the opinion of the Investigator will be at increased risk of above mentioned complications (Primary Group).

Exclusion Criteria

1.Subject has known allergy to the EndoAnchor implant material (nickel, chromium, molybdenum, or cobalt)
2.Subject has a life expectancy less than 1 year
3.Subject is participating in a clinical study or registry that, in the Investigator’s opinion, may conflict or may have a negative impact on the subject’s safety
4.Subject has already been implanted with an EndoAnchor device in a procedure performed prior to the index procedure
5.Subject has an active or known history of bleeding diathesis
6.Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
7.Infrarenal aortic neck with significant thrombus or calcium that precludes adequate EndoAnchor penetration of the aortic wall
8.Use where, for whatever reason, each EndoAnchor is not anticipated to adequately penetrate into the aortic wall.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint requires all of the following:<br>I.successful implantation of the minimum number of EndoAnchors™; the number defined by the diameter of the aortic neck, and<br>II.freedom from migration at 12 months following the index procedure, where migration is defined as >10mm movement of the aortic endograft from its position at the time of the index procedure, and<br>III.freedom from Type Ia endoleak at 12 months following the index procedure.<br>The primary safety endpoint is defined by:<br>I.freedom from device-related serious adverse events at 12 months following the index procedure, and<br>II.freedom from procedure-related serious adverse events at 12 months following the index procedure.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints have been chosen to reflect the clinical success and safety of the Aptus HeliFX Aortic Securement System. Each of the secondary endpoint will be measured individually with Kaplan-Meier estimates at 30 days, 6 months, and 12 months after the index procedure and yearly thereafter.<br>I.Clinical success will be defined as the successful implantation of the suggested number of EndoAnchors at the index procedure, and the absence of:<br>•Death as a result of aneurysm-related treatment<br>•Type Ia endoleak<br>•Endograft infection<br>•Endograft migration- defined as >10 mm movement of any component treated with HeliFX <br>•Loss of endograft fabric integrity as a result of the EndoAnchor<br>•Aneurysm rupture<br>•Conversion to open repair<br>II.Secondary aneurysm-related interventions after EndoAnchor implantation<br>III.All-cause mortality<br>IV.Freedom from EndoAnchor fracture<br><br>