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
Nellix Endovascular Inc.
20 participants
Nov 24, 2008
Interventional
Conditions
Summary
This study will determine the feasibility and safety of the Nellix Endograft System for use in patients with infrarenal abdominal aortic aneurysms.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- No acute renal failure
- No acutely ruptured or leaking aneurysm
- No other co-morbidity putting patient at risk
- Pregnant female
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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 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.
Locations(1)
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ACTRN12609000706279