The Nellix Endograft System for Abdominal Aortic Aneurysm Treatment

Phase 2

Recruiting

• Conditions: Aneurysms of the infrarenal aorta with or without iliac aneurysms; abdominal aortic aneurysms; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12609000706279
• Lead Sponsor: ellix Endovascular Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success will be measured by successful deployment of the endovascular graft with no major adverse events which include death, myocardial infarction, stroke, reintervention and endoleaks[Hospital discharge]

Secondary Outcome Measures

Name	Time	Method
Death[These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment];Cerebrovascular stroke by follow-up patient interview at clinic visit and hospital records[These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment];Reintervention to treat a failure of the device by either surgery or percutaneous procedure will be assessed by follow-up patient interview at clinic visit and hospital records[These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment];Endoleaks assessed by computerized tomography (CT) scans[These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment];Myocaridal Infarction by follow-up patient interview at clinic visit and hospital records[These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment]