Abdominal Aortic Aneurysm
Conditions
Keywords
AAA, Aortoiliac Aneurysm
Brief summary
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)
Interventions
DEVICENellix Endovascular Aneurysm Sealing System (Nellix®-System)
The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.
Sponsors
Endologix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female at least 18 years old 2. Subject has signed informed consent for data release 3. Subjects with with AAA and eligible for endovascular repair
Exclusion criteria
1. Currently participating in another study where primary endpoint has not been reached yet 2. Known allergy to any of the device components 3. Pregnant (females of childbearing potential only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with Immediate Procedural Technical Success | 30 Days | Technical success is defined as successful delivery and deployment of the Nellix System in the planned location. |
| Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) | 30 Days | Safety endpoint is measured with the number of subjects who are reported freedom of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss \> 1000mL at 30 Days post index procedure. |
| Number of subjects with Aneurysm rupture | 5 years | The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5). |
| Number of subjects with Conversion to open surgical repair | 5 years | The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5). |
| Number of subjects with Endoleak of any type | 5 years | The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized. |
| Number of subjects with Clinically significant migration | 5 years | The number of patients with clinically significant migration will be summarized descriptively. |
| Number of subjects with Aneurysm enlargement | 5 years | The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement. |
| Number of incidence with Secondary endovascular procedures | 5 years | The overall secondary procedure incidence and the individual component incidence will be provided. |
Countries
Germany, Netherlands, New Zealand, Spain
Contacts
PRINCIPAL_INVESTIGATORAndrew Holden, MBChB
Auckland City Hospital
PRINCIPAL_INVESTIGATORMichel Reijnen, MD
Rijnstate, Arnhem, the Netherlands
Outcome results
None listed