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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01437215




Registration number
NCT01437215
Ethics application status
Date submitted
17/09/2011
Date registered
20/09/2011
Date last updated
16/02/2024

Titles & IDs
Public title
Pilot Study of the Endologix Fenestrated Stent Graft System
Scientific title
Prospective, Multicenter, Single Arm Feasibility and Initial Safety Study of the Endologix Fenestrated Stent Graft System for the Endovascular Repair of Juxtarenal/Pararenal (JAA/PAA) Aneurysms
Secondary ID [1] 0 0
CP-0002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juxtarenal Aortic Aneurysm 0 0
Pararenal Aortic Aneurysm 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Ventana Fenestrated Stent Graft System

Experimental: Fenestrated Endografting -


Treatment: Devices: Ventana Fenestrated Stent Graft System
Endovascular repair of juxtarenal or pararenal aortic aneurysm
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety - Number of Major Adverse Events (MAEs)
Timepoint [1] 0 0
30 Days
Primary outcome [2] 0 0
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Timepoint [2] 0 0
30 Days
Secondary outcome [1] 0 0
Safety - Number of Major Adverse Events (MAEs)
Timepoint [1] 0 0
>30 Days to 5 Years
Secondary outcome [2] 0 0
Adverse Events
Timepoint [2] 0 0
Procedurally to 5 Years
Secondary outcome [3] 0 0
Distal Blood Flow
Timepoint [3] 0 0
Discharge to 5 Years
Secondary outcome [4] 0 0
Renal Dysfunction
Timepoint [4] 0 0
Discharge to 5 Years
Secondary outcome [5] 0 0
Device Performance
Timepoint [5] 0 0
30 Days to 5 Years

Eligibility
Key inclusion criteria
- Informed consent understood and signed and pt agrees to all follow-up visits;

- Abdominal aortic aneurysm with diameter =5cm or =4cm which has increased by 0.5cm or
more in the past six months

- Adequate iliac/femoral access compatible with the required delivery systems

- Non-aneurysmal infrarenal aortic neck <15mm in length

- Most caudal renal artery to aortoiliac bifurcation length at least 70mm

- Proximal non-aneurysmal aortic neck below the SMA with: diameter 18 to 34 mm; length
at least 15 mm; angle (clock face) <60° to the aneurysm sac;

- Angle <60° (clock face) between the SMA and celiac artery

- Renal arteries both distal to the SMA by 0-35mm, within 30mm of each other axially,
with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other

- Iliac anatomy suitable for commercial bifurcated stent graft;

- Minimum 3cm overlap achievable between fenestrated and bifurcated stent grafts
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy <1 year as judged by the investigator;

- Psychiatric or other condition that may interfere with the study;

- Participating in the enrollment or 30-day follow-up phase of another clinical study;

- Known allergy to any device component;

- Coagulopathy or uncontrolled bleeding disorder;

- Contraindication to contrast media or anticoagulants;

- Ruptured, leaking, dissecting, or mycotic aneurysm;

- Serum creatinine (S-Cr) level >2.0 mg/dL;

- Traumatic vascular injury;

- Active systemic or localized groin infection;

- Connective tissue disease (e.g., Marfan's Syndrome);

- Recent (within prior three months) cerebrovascular accident or myocardial infarction;

- Prior renal transplant;

- Length of either renal artery to be stented <13mm;

- Significant occlusive disease or calcification of either renal artery;

- An essential accessory renal artery;

- Indispensable inferior mesenteric artery;

- Untreated aneurysmal disease of the descending thoracic aorta;

- Clinically significant mural thrombus circumferentially in the suprarenal segment;

- Prior iliac artery stent implanted that may interfere with delivery system
introduction;

- Unsuitable vascular anatomy

- Pregnancy (female patient of childbearing potential only)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2016
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Endologix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether the Endologix fenestrated stent graft
system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic
aneurysm.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01437215
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01437215