Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Abdominal Aortic Aneurysms Clinical Trial

— PYTHAGORAS  

Official title:

Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522535
• Other study ID #: PYTHAGORAS
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: July 2020

Study information

• Verified date: October 2021
• Source: Lombard Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: July 2020
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• Open surgical repair
Open surgical repair of abdominal aortic aneurysm

Device:
• Stent Graft
Endovascular repair of abdominal aortic aneurysm (EVAR)

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	University of Michigan, Department of Vascular Surgery	Ann Arbor	Michigan
United States	John Hopkins Bayview Medical Center	Baltimore	Maryland
United States	UAB Vascular Surgery	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Tennessee	Chattanooga	Tennessee
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Englewood Hospital & Medical Center	Englewood	New Jersey
United States	Michigan Vascular Group	Flint	Michigan
United States	Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute	Fort Lauderdale	Florida
United States	University of Florida	Gainesville	Florida
United States	Pinnacle Health Hospitals	Harrisburg	Pennsylvania
United States	DeBakey Heart Center, Methodist Hospital	Houston	Texas
United States	Dartmouth - Hitchcock Medical	Lebanon	New Hampshire
United States	Long Beach VA Healthcare System	Long Beach	California
United States	Macon Cardiovascular Institute	Macon	Georgia
United States	University of Wisconsin School of Medicine & Public Health	Madison	Wisconsin
United States	Baptist Hospital of Miami, Cardiac & Vascular Institute	Miami	Florida
United States	Abbott Northwestern / MHIF	Minneapolis	Minnesota
United States	Yale University School of Medicine	New Haven	Connecticut
United States	New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Newark-Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Heart Hospital - Vascular & Transplant Specialists	Norfolk	Virginia
United States	Methodist Heart Lung & Vascular Institute	Peoria	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	UCSF Division of Vascular Surgery	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Sanford Clinic Clinical Research	Sioux Falls	South Dakota
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Springfield Memorial Hospital	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Jobst Vascular Center	Toledo	Ohio
United States	Harbor-UCLA Medical Center	Torrance	California
United States	University of Arizona, Department of Surgery	Tucson	Arizona
United States	Moffitt Heart and Vascular Group	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lombard Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aorfix™ vs. Open Control All Cause Mortality	The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.	1 year
Secondary	Aorfix™ vs. Open Control Adverse Events	The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.	30 days

External Links

•   Lombard Medical Technologies Inc. Homepage