Clinical trial NCT01348828: Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
Fenestrated
Renal Stent
Juxtarenal
Pararenal
Endologix
Renal
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 days
Secondary outcomes:
measure: Feasibility/Effectiveness
timeFrame: 1 Year
measure: Procedural/In-hospital Evaluations
timeFrame: Procedurally and to hospital discharge
measure: Mortality
timeFrame: Procedurally and to 5 Years
measure: Major Adverse Events
timeFrame: >30 Days to 5 Years
measure: Number of Participants With Renal Dysfunction
timeFrame: 30 Days, 6 Months and Years 1 to 5
measure: Aneurysm Rupture
timeFrame: Procedurally and to 5 Years
measure: Conversion to Open Repair
timeFrame: Procedurally and to 5 Years
measure: Device Integrity
timeFrame: 30 Days, 6 Months, and Years 1 to 5
measure: Stent Graft Patency
timeFrame: 30 Days, 6 Months, and Years 1 to 5
measure: Aneurysm Diameter Change
timeFrame: 6 Months, and Years 1 to 5
measure: Secondary Procedures
timeFrame: 30 Days, 6 Month and Years 1 to 5
measure: Procedural/In-hospital Evaluations
timeFrame: Procedurally and to hospital discharge
measure: Procedural/In-hospital Evaluations
timeFrame: Discharge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Indianapolis
country: United States
facility: University of Indiana
state: Indiana
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Santiago
country: Chile
facility: Hospital Universidad Catolica
city: Creteil
country: France
facility: Bureau de Recherche Clinique
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: London
country: United Kingdom
facility: St. George's Vascular Institute
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Clair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universidad Catolica
name: Renato Mertens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.