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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01348828
Ethics application status
Date submitted
3/05/2011
Date registered
5/05/2011
Date last updated
15/10/2021

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)

Other: Single Arm - All patients meet study criteria receives a single use Ventana Fenestrated System, which requires administration of intravascular contrast. Catheter advancement is performed under fluoroscopic guidance and Ventana Fenestrated System is placed.


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
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Feasibility/Effectiveness
Timepoint [1] 0 0
1 Year
Secondary outcome [2] 0 0
Procedural/In-hospital Evaluations
Timepoint [2] 0 0
Procedurally and to hospital discharge
Secondary outcome [3] 0 0
Mortality
Timepoint [3] 0 0
Procedurally and to 5 Years
Secondary outcome [4] 0 0
Major Adverse Events
Timepoint [4] 0 0
>30 Days to 5 Years
Secondary outcome [5] 0 0
Number of Participants With Renal Dysfunction
Timepoint [5] 0 0
30 Days, 6 Months and Years 1 to 5
Secondary outcome [6] 0 0
Aneurysm Rupture
Timepoint [6] 0 0
Procedurally and to 5 Years
Secondary outcome [7] 0 0
Conversion to Open Repair
Timepoint [7] 0 0
Procedurally and to 5 Years
Secondary outcome [8] 0 0
Device Integrity
Timepoint [8] 0 0
30 Days, 6 Months, and Years 1 to 5
Secondary outcome [9] 0 0
Stent Graft Patency
Timepoint [9] 0 0
30 Days, 6 Months, and Years 1 to 5
Secondary outcome [10] 0 0
Aneurysm Diameter Change
Timepoint [10] 0 0
6 Months, and Years 1 to 5
Secondary outcome [11] 0 0
Secondary Procedures
Timepoint [11] 0 0
30 Days, 6 Month and Years 1 to 5
Secondary outcome [12] 0 0
Procedural/In-hospital Evaluations
Timepoint [12] 0 0
Procedurally and to hospital discharge
Secondary outcome [13] 0 0
Procedural/In-hospital Evaluations
Timepoint [13] 0 0
Discharge

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
Sex
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
Not applicable
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
19/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/03/2018
Sample size
Target
Accrual to date
Final
49
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/study/NCT01348828
Trial related presentations / publications
Mertens R, Bergoeing M, Marine L, Valdes F, Kramer A, Vergara J. Ventana fenestrated stent-graft system for endovascular repair of juxtarenal aortic aneurysms. J Endovasc Ther. 2012 Apr;19(2):173-8. doi: 10.1583/11-3706.1.
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/study/NCT01348828