Back to resultsPilot Study of the Endologix Fenestrated Stent Graft System
Primary Purpose
Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ventana Fenestrated Stent Graft System
Sponsored by
About this trial
This is an interventional treatment trial for Juxtarenal Aortic Aneurysm focused on measuring aneurysm, renal stent, juxtarenal, pararenal
Eligibility Criteria
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
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)
Sites / Locations
- Pontificia Universidad Católica de Chile
- Auckland City Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fenestrated Endografting
Arm Description
Outcomes
Primary Outcome Measures
Safety - Number of Major Adverse Events (MAEs)
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Secondary Outcome Measures
Safety - Number of Major Adverse Events (MAEs)
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Adverse Events
All adverse events, whether serious or non-serious
Distal Blood Flow
Ankle-brachial index measurements
Renal Dysfunction
eGFR reduction >30% from baseline
Device Performance
Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01437215
Brief Title
Pilot Study of the Endologix Fenestrated Stent Graft System
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2010 (Actual)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
July 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm
Keywords
aneurysm, renal stent, juxtarenal, pararenal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenestrated Endografting
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ventana Fenestrated Stent Graft System
Intervention Description
Endovascular repair of juxtarenal or pararenal aortic aneurysm
Primary Outcome Measure Information:
Title
Safety - Number of Major Adverse Events (MAEs)
Description
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Time Frame
30 Days
Title
Feasibility- Number of subjects with procedural success (stent graft patency) and absence of type I/III endoleaks or migration
Description
Procedural Success with aortic/fenestrated and renal stent graft patency and absence of Type I/III endoleak or migration
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Safety - Number of Major Adverse Events (MAEs)
Description
Major Adverse Events = all cause death; bowel ischemia; myocardial infarction; paraplegia; renal failure; respiratory complications of stroke; blood loss >1000cc
Time Frame
>30 Days to 5 Years
Title
Adverse Events
Description
All adverse events, whether serious or non-serious
Time Frame
Procedurally to 5 Years
Title
Distal Blood Flow
Description
Ankle-brachial index measurements
Time Frame
Discharge to 5 Years
Title
Renal Dysfunction
Description
eGFR reduction >30% from baseline
Time Frame
Discharge to 5 Years
Title
Device Performance
Description
Aortic, fenestrated, and renal stent graft integrity and patency; migration; endoleak; and aneurysm sac morphology
Time Frame
30 Days to 5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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)
Facility Information:
Facility Name
Pontificia Universidad Católica de Chile
City
Santiago
Country
Chile
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
23466185
Citation
Holden A, Mertens R, Hill A, Marine L, Clair DG. Initial experience with the Ventana fenestrated system for endovascular repair of juxtarenal and pararenal aortic aneurysms. J Vasc Surg. 2013 May;57(5):1235-45. doi: 10.1016/j.jvs.2012.10.125. Epub 2013 Mar 5.
Results Reference
derived
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Pilot Study of the Endologix Fenestrated Stent Graft System
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