Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000706279
Ethics application status
Approved
Date submitted
2/10/2008
Date registered
14/08/2009
Date last updated
14/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Nellix Endograft System for Abdominal Aortic Aneurysm Treatment
Scientific title
Feasibility and safety study of the Nellix Endograft System for Exclusion of infrarenal aortic or aorto-iliac abdominal aortic aneurysms
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aneurysms of the infrarenal aorta with or without iliac aneurysms 3782 0
abdominal aortic aneurysms 4020 0
Condition category
Condition code
Cardiovascular 3957 3957 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 4225 4225 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3495 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4860 0
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
Timepoint [1] 4860 0
Hospital discharge
Secondary outcome [1] 8613 0
Death
Timepoint [1] 8613 0
These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment
Secondary outcome [2] 8615 0
Cerebrovascular stroke by follow-up patient interview at clinic visit and hospital records
Timepoint [2] 8615 0
These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment
Secondary outcome [3] 8616 0
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
Timepoint [3] 8616 0
These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment
Secondary outcome [4] 8617 0
Endoleaks assessed by computerized tomography (CT) scans
Timepoint [4] 8617 0
These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment
Secondary outcome [5] 257133 0
Myocaridal Infarction by follow-up patient interview at clinic visit and hospital records
Timepoint [5] 257133 0
These outcomes will be assessed at 30 days, 6 months, and 1 and 2 years after conclusion of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No acute renal failure
No acutely ruptured or leaking aneurysm
No other co-morbidity putting patient at risk
Pregnant female

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Screening thoraco-abdominal-peripheral CT scans by treating physicians to determine eligibility will be used.
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 1245 0
Latvia
State/province [1] 1245 0

Funding & Sponsors
Funding source category [1] 4206 0
Commercial sector/Industry
Name [1] 4206 0
Nellix Endovascular, Inc.
Country [1] 4206 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nellix Endovascular Inc.
Address
2465 Faber Place
Palo Alto, California 94303
Country
United States of America
Secondary sponsor category [1] 236959 0
None
Name [1] 236959 0
Address [1] 236959 0
Country [1] 236959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6260 0
ETHICS COMMITTEE FOR CLINICAL RESEARCH
Ethics committee address [1] 6260 0
P.Stradins Clinical University Hospital Development Foundation
Pilsonu street 13, Riga, LV- 1002
Ethics committee country [1] 6260 0
Latvia
Date submitted for ethics approval [1] 6260 0
13/10/2008
Approval date [1] 6260 0
17/10/2008
Ethics approval number [1] 6260 0

Summary
Brief summary
This study will determine the feasibility and safety of the Nellix Endograft System for use in patients with infrarenal abdominal aortic aneurysms.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 28997 0
Address 28997 0
Country 28997 0
Phone 28997 0
Fax 28997 0
Email 28997 0
Contact person for public queries
Name 12154 0
Paulette Niemyski
Address 12154 0
2465 Faber Place
Palo Alto, California 94303
Country 12154 0
United States of America
Phone 12154 0
+1-650-213-8700
Fax 12154 0
Email 12154 0
[email protected]
Contact person for scientific queries
Name 3082 0
Paulette Niemyski
Address 3082 0
2465 Faber Place
Palo Alto, California 94303
Country 3082 0
United States of America
Phone 3082 0
+1-650-213-8700
Fax 3082 0
Email 3082 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.