Skip to content

The Nellix Endograft System for Abdominal Aortic Aneurysm Treatment

Feasibility and safety study of the Nellix Endograft System for Exclusion of infrarenal aortic or aorto-iliac abdominal aortic aneurysms

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000706279
Enrollment
20
Registered
2009-08-14
Start date
2008-11-24
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will determine the feasibility and safety of the Nellix Endograft System for use in patients with infrarenal abdominal aortic aneurysms.

Interventions

The Nellix AAA System is a catheter based system used to treat aneurysms between the renal and iliac arteries by excluding the aneurysm sac thereby preventing rupture. The System includes two Nellix Cathters placed into the vascular space via the femoral arteries. The Nellix Implant is positioned below the renal arteries and will terminate in each of the common iliac arteries. After positioning the Nellix catheters across the aneurysm, the Deployment Balloons are simultaneously inflated to dep

The Nellix AAA System is a catheter based system used to treat aneurysms between the renal and iliac arteries by excluding the aneurysm sac thereby preventing rupture. The System includes two Nellix Cathters placed into the vascular space via the femoral arteries. The Nellix Implant is positioned below the renal arteries and will terminate in each of the common iliac arteries. After positioning the Nellix catheters across the aneurysm, the Deployment Balloons are simultaneously inflated to deploy the Endoframe, and then deflated. The in-situ curing Polymer material is injected into the Endobag, thereby expanding the bag to fill the aneurysmal space between the Endoframe and the sac wall and excluding the aneurysm which forms the Implant. The Endoframe/Endobag is then released from the Nellix Catheter and the Catheters are removed from the patient. The average Nellix procedure time is approximately 45 to 60 minutes.

Sponsors

Nellix Endovascular Inc.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient greater than or equal to 18 years of age Candidate for open surgical repair of abdominal aneurysm Abdominal aneurysm diameter >4 cm Aortic neck diameter 18-26 mm Able to return for follow-up visits

Exclusion criteria

No acute renal failure No acutely ruptured or leaking aneurysm No other co-morbidity putting patient at risk Pregnant female

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026