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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01348828




Registration number
NCT01348828
Ethics application status
Date submitted
3/05/2011
Date registered
5/05/2011
Date last updated
6/06/2013

Titles & IDs
Public title
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
Scientific title
Prospective, Multicenter, Single Arm Feasibility and 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-0003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal 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 - Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)

Treatment: Devices: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint - Major adverse events defined as:
All-cause death
Bowel ischemia
Myocardial infarction
Paraplegia
Renal failure
Respiratory failure
Stroke
Blood loss >=1,000cc
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Feasibility/effectiveness - Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.
Timepoint [1] 0 0
30 Days
Secondary outcome [2] 0 0
Procedural/in-hospital evaluations - Anesthesia time; fluoroscopy time; contrast volume; estimated blood loss; % requiring transfusion; procedure time; ICU time; time to hospital discharge
Timepoint [2] 0 0
Procedurally and to hospital discharge
Secondary outcome [3] 0 0
Mortality - All-cause and aneurysm-related
Timepoint [3] 0 0
Procedurally and to 5 Years
Secondary outcome [4] 0 0
Major Adverse Events - All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss >1,000cc
Timepoint [4] 0 0
>30 Days to 5 Years
Secondary outcome [5] 0 0
Adverse Events - All serious and non-serious adverse events
Timepoint [5] 0 0
Procedurally and to 5 Years
Secondary outcome [6] 0 0
Renal Dysfunction - Reduction in estimated glomerular filtration rate (eGFR) >30% from the preoperative value
Timepoint [6] 0 0
30 Days, 6 Months and Years 1 to 5
Secondary outcome [7] 0 0
Aneurysm Rupture - Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Timepoint [7] 0 0
Procedurally and to 5 Years
Secondary outcome [8] 0 0
Conversion to Open Repair - Open surgical repair of the aortic aneurysm due to unsuccessful delivery or deployment of the stent graft, due to complications or other clinical situations that precluded successful endovascular treatment, or at any time following initial successful endovascular treatment for any reason
Timepoint [8] 0 0
Procedurally and to 5 Years
Secondary outcome [9] 0 0
Distal Blood Flow - Ankle-brachial index measurements and changes over time
Timepoint [9] 0 0
Pre-discharge, 30 Days, 6 Months, and Years 1 to 5
Secondary outcome [10] 0 0
Renal Stent Graft Patency and Integrity - Patent luminal flow; absence of kinking, stenosis, occlusion, stent fracture, graft failure, or renal infarct >30%
Timepoint [10] 0 0
30 Days, 6 Months, and Years 1 to 5
Secondary outcome [11] 0 0
Stent Graft Patency and Integrity - Bifurcated and fenestrated stent graft patent luminal flow; absence of stent fracture or graft fatigue/failure
Timepoint [11] 0 0
30 Days, 6 Months, and Years 1 to 5
Secondary outcome [12] 0 0
Endograft Performance - Change in aneurysm sac diameter from the first post-procedural measurement; incidence of endoleak; incidence of device migration; incidence of limb occlusion
Timepoint [12] 0 0
30 Days, 6 Months, and Years 1 to 5
Secondary outcome [13] 0 0
Secondary Procedures - Non-diagnostic intervention after the index procedure intended to correct or repair an endoleak (device-related: Type I (proximal or distal), Type III, Type IV; non-device related: Type II), device migration, or other device defect.
Timepoint [13] 0 0
30 Days, 6 Months, and Years 1 to 5

Eligibility
Key inclusion criteria
- 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 >= 70

- SMA to aortoiliac bifurcation length >=90mm

- Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length
>=15mm and angle <=60° to the aneurysm sac

- Angle <=60° (clock face) between the SMA and CA

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

- Common iliac artery distal fixation site with: distal fixation length >=15mm, with
diameter >=10 mm and <=23 mm and angle <=90° to the aortic bifurcation

- Ability to preserve at least one hypogastric artery
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy <2 years 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, or mycotic aneurysm

- Aortic dissection 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

- Recent(within prior three months)myocardial infarction

- Prior renal transplant

- Length of either renal artery to be stented <12mm

- Significant occlusive disease or calcification of either renal artery (>70%)

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
Chile
State/province [4] 0 0
Santiago
Country [5] 0 0
France
State/province [5] 0 0
Creteil
Country [6] 0 0
Netherlands
State/province [6] 0 0
Arnhem
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated
Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
Trial website
https://clinicaltrials.gov/show/NCT01348828
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Clair, MD
Address 0 0
The Cleveland Clinic
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/show/NCT01348828