Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
- Conditions
- Abdominal Aortic Aneurysm
- Interventions
- Device: Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)
- Registration Number
- NCT01348828
- Lead Sponsor
- Endologix
- 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.
- Detailed Description
The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:
1. Endologix unibody bifurcated stent graft
2. Endologix fenestrated proximal extension stent graft
3. Endologix renal stent graft
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System) 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.
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint 30 days Major adverse events defined as:
* All-cause death
* Bowel ischemia
* Myocardial infarction
* Paraplegia
* Renal failure
* Respiratory failure
* Stroke
* Blood loss \>=1,000cc
- Secondary Outcome Measures
Name Time Method Mortality Procedurally and to 5 Years All-cause and aneurysm-related
Feasibility/Effectiveness 1 Year Successful device delivery and deployment with patency of the renal and aortic endografts without Type I/III endoleak.
1. Treatment Success is defined as procedural technical success with device patency and the absence of type I/III endoleak
2. Procedural Technical Success is defined as a subject with successful implant.
3. Aneurysm Rupture: An aneurysm is a balloon-like bulge of an artery wall. As an aneurysm grows it puts pressure on nearby structures and may eventually rupture.
4. Clinically Significant Device Migration: Core Lab reported aortic stent graft movement \>10mm
5. Type I/III/IV Endoleak: Core Lab reported endoleak: between the endograft and the vessel either at the proximal attachment point (Type IA), or at the distal attachment point (Type IB), or between endograft components (Type III) or transgraft (Type IV).
6. Type II Endoleak: Core Lab reported endoleak emanating from a patent collateral vessel (e.g., inferior mesenteric artery, lumbar artery).Stent Graft Patency 30 Days, 6 Months, and Years 1 to 5 Ventana and Bifurcated occlusion, LRA (Left renal artery) occlusion and RRA (right renal artery) occlusion
Major Adverse Events >30 Days to 5 Years All-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, blood loss \>1,000cc
Number of Participants With Renal Dysfunction 30 Days, 6 Months and Years 1 to 5 Renal Dysfunction, Renal Dysfunction In subjects with baseline eGFR\>=60 and Renal Dysfunction In subjects with baseline eGFR \<60
Aneurysm Rupture Procedurally and to 5 Years Internal bleeding or leaking of blood from the aneurysm subsequent to the index procedure
Device Integrity 30 Days, 6 Months, and Years 1 to 5 Device Migration, Ventana Stent Fracture, Left renal stent fracture, right renal stent fracture, stent Kinking/Compression
Aneurysm Diameter Change 6 Months, and Years 1 to 5 Change in aneurysm sac diameter - decrease \> 5mm, Increase \> 5mm, Stable (+/- 5mm) and No growth.
Procedural/In-hospital Evaluations Discharge Time to hospital discharge
Secondary Procedures 30 Days, 6 Month and Years 1 to 5 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.
Conversion to Open Repair Procedurally and to 5 Years 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
Trial Locations
- Locations (8)
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
University of Indiana
🇺🇸Indianapolis, Indiana, United States
Hospital Universidad Catolica
🇨🇱Santiago, Chile
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
UCLA
🇺🇸Los Angeles, California, United States
Bureau de Recherche Clinique
🇫🇷Creteil, France
Auckland City Hospital
🇳🇿Auckland, New Zealand
St. George's Vascular Institute
🇬🇧London, United Kingdom