Clinical trial NCT00522535: Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Official title: Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysms
Keywords: AAA
Abdominal Aortic Aneurysms
Endovascular
EVAR
Aorta
Stent Graft
Stent
Tortuous
High Angle
Angled Necks
Lead sponsor: Lombard Medical
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 230
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.

Study hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.

Efficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.

Safety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.


Eligibility criteria: Inclusion Criteria:

* Diagnosed abdominal aortic aneurysm \> 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or
* Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.

Exclusion Criteria:

* Less than 21 years of age,
* Life expectancy less than 2 years,
* Pregnant,
* Religious cultural or other objection to the receipt of blood or blood products,
* Unwilling to comply with follow-up schedule,
* Unwillingness or inability to provide informed consent to both trial and procedure.
* Patients not expected to live more than 2 years from enrollment
* Patient has a ruptured aneurysm
* Aneurysm extends above renal arteries
* Proximal neck of aneurysm has significant loose thrombus associated with it
* Patient with an acute or chronic aortic dissection or mycotic aneurysm
* Patient has current non-localized infection (may be recruited following remission of the infection)
* Patient is allergic to device materials
* Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl
* Patient is clinically and morbidly obese such that imaging would be severely adversely affected
* Patient has renal failure (serum creatinine \> 2.5 mg/dL)
* Patient has an uncorrectable bleeding abnormality
* Patient has unstable angina
* Patient is receiving dialysis:
* Inflammatory aneurysm
* MI in last 6 months
* End stage COPD
* Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)
* Significant (\>80%) renal artery stenosis which cannot be readily treated

Primary outcomes:
measure: Aorfix™ vs. Open Control All Cause Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Aorfix™ vs. Open Control Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Vascular Surgery
state: Alabama
city: Tucson
country: United States
facility: University of Arizona, Department of Surgery
state: Arizona
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: San Francisco
country: United States
facility: UCSF Division of Vascular Surgery
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami, Cardiac & Vascular Institute
state: Florida
city: Macon
country: United States
facility: Macon Cardiovascular Institute
state: Georgia
city: Peoria
country: United States
facility: Methodist Heart Lung & Vascular Institute
state: Illinois
city: Springfield
country: United States
facility: Springfield Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan, Department of Vascular Surgery
state: Michigan
city: Flint
country: United States
facility: Michigan Vascular Group
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern / MHIF
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth - Hitchcock Medical
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital & Medical Center
state: New Jersey
city: Newark
country: United States
facility: Newark-Beth Israel Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery
state: New York
city: Toledo
country: United States
facility: Jobst Vascular Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Moffitt Heart and Vascular Group
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Clinic Clinical Research
state: South Dakota
city: Chattanooga
country: United States
facility: University of Tennessee
state: Tennessee
city: Houston
country: United States
facility: DeBakey Heart Center, Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Heart Hospital - Vascular & Transplant Specialists
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin School of Medicine & Public Health
state: Wisconsin
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Mark Fillinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang S, Hicks CW, Malas MB. Neck diameter and inner curve seal zone predict endograft-related complications in highly angulated necks after endovascular aneurysm repair using the Aorfix endograft. J Vasc Surg. 2018 Mar;67(3):760-769. doi: 10.1016/j.jvs.2017.07.114. Epub 2017 Sep 21.
citation: Malas MB, Hicks CW, Jordan WD Jr, Hodgson KJ, Mills JL Sr, Makaroun MS, Belkin M, Fillinger MF; PYTHAGORAS Investigators. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. J Vasc Surg. 2017 Jun;65(6):1598-1607. doi: 10.1016/j.jvs.2016.10.120. Epub 2017 Feb 9.
citation: Malas MB, Jordan WD, Cooper MA, Qazi U, Beck AW, Belkin M, Robinson W, Fillinger M. Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial. J Vasc Surg. 2015 Nov;62(5):1108-17. doi: 10.1016/j.jvs.2015.05.042. Epub 2015 Aug 28.